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Carestream Health, Inc.

89 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
DRX Revolution Mobile X-Ray System recall (Z-0437-2024)Carestream Health, Inc.2023-12-01
The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digit recall (Z-0289-2024)Carestream Health, Inc.2023-11-09
DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaini recall (Z-1206-2023)Carestream Health, Inc.2023-03-02
DRX-Revolution Mobile X-Ray System; MODEL DRXR-1; Catalog # 1019397 (all other countries) recall (Z-2651-2017)Carestream Health Inc2017-06-19
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasou recall (Z-1052-2017)Carestream Health Inc2017-01-19
Carestream Touch Prime, Catalog Number 1738830, and Carestream Touch Prime XE, Catalog Num recall (Z-2217-2016)Carestream Health Inc2016-07-18
CARESTREAM Image Suite V3: MINI-PACS/F IMG ST/CLASSIC: REF/Catalog # 1036490; MINI-PACS/F recall (Z-1593-2016)Carestream Health Inc2016-05-02
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM S recall (Z-1594-2016)Carestream Health Inc2016-05-02
CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed recall (Z-2449-2015)Carestream Health Inc2015-08-22
CS 8100, CATALOG # (s): 5303045, 5311129, 5303060, 5303110 Intended to produce complete or recall (Z-1377-2015)Carestream Health, Inc.2015-04-03
CS 8100 3D, CATALOG # (s): 5311162, 5311188. Intended to produce complete or segmented tom recall (Z-1378-2015)Carestream Health, Inc.2015-04-03
CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can be used f recall (Z-0820-2015)Carestream Health, Inc.2014-12-17
DRX-Revolution Mobile X-Ray System, MODEL DRXR-1, Service Code 1243, Catalog Number 106017 recall (Z-0800-2015)Carestream Health Inc2014-12-16
Kodak DirectView DR 7500 Diagnostic X-Ray System Product Usage: The DR 7500 system is a pe recall (Z-2177-2014)Carestream Health, Inc.2014-08-10
KODAK DirectView DR 9000 System, Catalog Numbers 1966688 (US and Canada) and 8161937 (outs recall (Z-2137-2014)Carestream Health Inc.2014-08-01
INSIGHT Dental Film, Catalog Number/REF 811 0785, KODAK and Carestream DENTAL labels --- C recall (Z-2142-2014)Carestream Health Inc.2014-08-01
Ultra-speed Dental Film, Catalog Number/REF 834 8658, KODAK and Carestream DENTAL labels - recall (Z-2143-2014)Carestream Health Inc.2014-08-01
Model Kodak 2100 Intraoral X-Ray System, Catalog Numbers 5303144, 8011579 -- Carestream He recall (Z-1127-2014)Carestream Health Inc.2014-03-04
Model Kodak 2200 Intraoral X-Ray System, Catalog Numbers 5303177, 5303169, 5303151, XR-515 recall (Z-1128-2014)Carestream Health Inc.2014-03-04
Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard Q) is a pe recall (Z-0774-2014)Carestream Health Inc.2014-01-29
KODAK DirectView DR 7500 Dual Detector System, MODEL DR 7500, Manufactured by Carestream H recall (Z-0844-2014)Carestream Health, Inc.2014-01-27
DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems recall (Z-0796-2014)Carestream Health, Inc.2014-01-21
DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray system recall (Z-0797-2014)Carestream Health, Inc.2014-01-21
DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems compo recall (Z-0798-2014)Carestream Health, Inc.2014-01-21
Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. recall (Z-0491-2014)Carestream Health Inc.2014-01-03
Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image ma recall (Z-0211-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual Access Plus SW, Workgroup The CARESTREAM PACS is an image man recall (Z-0212-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual PWR Reading Basic SW, Workgroup The CARESTREAM PACS is an ima recall (Z-0213-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual PWR Reading Basic SW, 8 Pack The CARESTREAM PACS is an image recall (Z-0214-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual PWR Reading Basic SW Workgroup The CARESTREAM PACS is an imag recall (Z-0215-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual PWR Reading Basic SW 8 Pack The CARESTREAM PACS is an image m recall (Z-0216-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual Access Software, StandAlone The CARESTREAM PACS is an image m recall (Z-0217-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual Access Pluse SW, StandAlone The CARESTREAM PACS is an image m recall (Z-0218-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual Enterprise SW StandAlone The CARESTREAM PACS is an image mana recall (Z-0219-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual PWR Reading Basic SW StandAlone The CARESTREAM PACS is an ima recall (Z-0220-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Virtual Reading Basic SW StandAlone The CARESTREAM PACS is an image m recall (Z-0221-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Unlimited Reading LIC<7.5K EX/YR The CARESTREAM PACS is an image mana recall (Z-0222-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; Unlimited Reading LIC<15K EX/YR The CARESTREAM PACS is an image manag recall (Z-0223-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<7.5K EX/Y The CARESTREAM PACS is an image m recall (Z-0224-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<15K EXAMS The CARESTREAM PACS is an image m recall (Z-0225-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UNLIMITED READING LIC < 25K EX/YR The CARESTREAM PACS is an image man recall (Z-0226-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UNLIMITED READING LIC < 50K EX/YR The CARESTREAM PACS is an image man recall (Z-0227-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UNLIMITED READING LIC ADD 10K EX/YR The CARESTREAM PACS is an image m recall (Z-0228-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UNLIMITED READING LIC ADD 25K EX/YR The CARESTREAM PACS is an image m recall (Z-0229-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UNLIMITED READING LIC ADD 100K E/YR The CARESTREAM PACS is an image m recall (Z-0230-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX-O SA WORKSTATION SW LICENSE The CARESTREAM PACS is an image manage recall (Z-0231-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX CLINIC SOFTWARE DICOM VIEWING The CARESTREAM PACS is an image mana recall (Z-0232-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX RAD SW ADV CR/DR LAYOUT & VIEW The CARESTREAM PACS is an image man recall (Z-0233-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX PRINT SW AUTO LAYOUT PAGE & PRINT The CARESTREAM PACS is an image recall (Z-0234-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC< 7.5K EXAMS The CARESTREAM PACS is an image m recall (Z-0235-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 15K EXAMS The CARESTREAM PACS is an image m recall (Z-0236-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 25K EXAMS The CARESTREAM PACS is an image m recall (Z-0237-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 50K EXAMS The CARESTREAM PACS is an image m recall (Z-0238-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-O LIC < 75K EXAMS The CARESTREAM PACS is an image m recall (Z-0239-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image man recall (Z-0240-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0241-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0242-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0243-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0244-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0245-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-O SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image mana recall (Z-0246-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SW/ 1 MX-O CONCUR ACCESS LIC The CARESTREAM PACS is an image m recall (Z-0247-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<75K EX/YR The CARESTREAM PACS is an image m recall (Z-0248-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<50K EX/YR The CARESTREAM PACS is an image m recall (Z-0249-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SVR W/3 MX-RAD LIC<25K EXAMS The CARESTREAM PACS is an image m recall (Z-0250-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SW/1 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image ma recall (Z-0251-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SW/5 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image ma recall (Z-0252-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SW/10 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image m recall (Z-0253-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SW/15 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image m recall (Z-0254-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; MX WEB SW/25 MX-RAD CONCUR USER LIC The CARESTREAM PACS is an image m recall (Z-0255-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-RAD SVR 7.5K EX/YR UNLIMITED The CARESTREAM PACS is an image m recall (Z-0256-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-RAD SVR 15K EX/YR UNLIMITED The CARESTREAM PACS is an image ma recall (Z-0257-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-RAD SVR 25K EX/YR UNLIMITED The CARESTREAM PACS is an image ma recall (Z-0258-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-RAD SVR 50K EX/YR UNLIMITED The CARESTREAM PACS is an image ma recall (Z-0259-2014)Carestream Health Inc.2013-11-13
Carestream Vue PACS; UPG MX-RAD SVR 75K EX/YR UNLIMITED The CARESTREAM PACS is an image ma recall (Z-0260-2014)Carestream Health Inc.2013-11-13
DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream H recall (Z-0179-2014)Carestream Health Inc.2013-11-07
CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream recall (Z-0180-2014)Carestream Health Inc.2013-11-07
DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and recall (Z-0132-2014)Carestream Health Inc.2013-11-01
DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalo recall (Z-0090-2014)Carestream Health, Inc.2013-10-31
Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images. recall (Z-0126-2014)Carestream Health, Inc.2013-10-31
Carestream DRX Evolution System, X-Ray System --- The DRX-Evolution system is a permanentl recall (Z-1877-2013)Carestream Health Inc.2013-08-12
KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP2 recall (Z-0744-2013)Carestream Health, Inc.2013-01-28
Carestream DRX-1 System Battery --- Made in U.S.A. for Carestream Health, Inc., Carestream recall (Z-2202-2012)Carestream Health, Inc.2012-08-13
DVB KODAK DRYVIEW --- 35x43 cm --- 125 SHT --- REF 8723132 --- Made in U.S.A. by Carestrea recall (Z-0746-2012)Carestream Health, Inc.2012-01-13
KODAK T-MAT L/RA Film, Catalog/REF # 181 4631, 35x43 cm 5-100 Sheet Boxes Folhas/Hojas, Ma recall (Z-1314-2010)Carestream Health, Inc.2010-04-08
KODAK T-MAT G/RA Film, Catalog/REF # 151 0023, 24x30 cm, 5-100 Sheet Boxes FOLHAS/Hojas, M recall (Z-1315-2010)Carestream Health, Inc.2010-04-08
Kodak DirectView Model DR 3000 System, Stationary X-ray System; Catalog #s 6551360, 655138 recall (Z-0731-2008)Carestream Health, Inc.2008-02-23
Kodak Direct View DR3000 System, Stationary X-ray System, Catalog #s 655-1345, 655-1386. recall (Z-0717-2007)Carestream Health, Inc.2007-07-03
Kodak Direct View DR7500 System, Catalog #s 855-1046, 879-1345, 161-9139 --- A stationary recall (Z-0738-2007)Carestream Health, Inc.2007-06-30

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