DigitalDiagnost X-ray System is a stationary Diagnostic X-ray using Digital Solid State Imaging Detector. It is identifi
FDA device recall Z-2422-2010 · posted 2010-09-14 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- When using DICOM print functionality, the printed images may contain data for the wrong patient.
- Action taken
- Philips Healthcare issued an "URGENT PRODUCT CORRECTION " letter dated March 10, 2008 to their consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: 1) Validate that image and patient information are correct on hard copy prints. 2) Reprint images that have mixed patient information, and re-check that image and patient information are correct. 3) Do not use printed images if the information is incorrect. The firm will issue the Field Change Order (FCO) 71200025 and the field service engineers will visit each consignee and conduct a software upgrade to solves the printing problem. The consignees may contact the Philips Call Center at 1-800-772-9377, #5 #2 and reference "FCO 71200025".
- Root cause
- Software design
- Status
- Terminated
- Product code
- KPR
- Quantity affected
- 119 units
- Distribution
- Nationwide Distribution: including the states of AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VT, WA, and WI.
- Date initiated
- 2007-12-13
- Date posted
- 2010-09-14
- Date terminated
- 2010-09-14
- Location
- Bothell, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BUCKY VISION (K982795) | Philips Medical Systems, Inc. | 1998-11-24 |