Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR i
FDA device recall Z-1964-2013 · posted 2013-08-21 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3).
- Action taken
- Phillips Healthcare sent an Important Notification letter dated July 10, 2013 to all affected customer. The notification informed customers that Philips will implement an update to the Instruction for Use (IFU). Philips will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services. For questions contact your local Philips representative or local Philips Healthcare office.
- Root cause
- Radiation Control for Health and Safety Act
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 240 systems US -- 1 system within Puerto Rico
- Distribution
- US Nationwide Distribution including Puerto Rico
- Date initiated
- 2013-06-11
- Date posted
- 2013-08-21
- Date terminated
- 2017-01-12
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOBILEDIAGNOST WDR (K111725) | Sedecal., Sa. | 2011-07-19 |