Biograph mCT Flow Edge-4R, Material Number 10528955 The Siemens Biograph mCT and Biograph mCT Flow systems are combined
FDA device recall Z-1001-2017 · posted 2017-01-10 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA Inc.
- Reason for recall
- Siemens Medical Solutions, Molecular Imaging has become aware, through our supplier that some laser cover windows may fall off.
- Action taken
- Siemens Healthineers sent a Customer Safety Advisory Notice letter on December 13, 2016. The letter states that the light marker windows used for the positioning laser and integrated into the front cover of the Biograph mCT or Biograph mCT Flow system may loosen and potentially drop out and warning the consignee not to use the system of the front cover is loose or missing. Customers with questions were instructed to contact their local Siemens representative at the following numbers: America 1-800-888-7436 Europe, Middle East and Africa +49 9131 940 4000 Asia and Australia +86 (21) 3811 2121 For questions regarding this recall call 865-218-2000.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KPS
- Quantity affected
- 1 unit
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to U.A.E., AT, AU, AZ, BR, CA, ,CH, CL, CN, CO, CZ, DE, DK, EG,FI, FR, GB, HK, HR, IL, IN, IR, IT, JP, KR, MX, NL, NO, NZ, PK, PL, QA, RO R
- Date initiated
- 2016-12-13
- Date posted
- 2017-01-10
- Date terminated
- 2017-05-08
- Location
- Knoxville, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Biograph mCT and mCT Flow PET/CT Scanners (K151486) | Siemens Medical Solutions USA, Inc. | 2015-07-17 |