Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Prod
FDA device recall Z-2494-2012 · posted 2012-09-28 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator
- Action taken
- Philips Healthcare sent an Urgent Field Safety Notice letter dated August 15, 2012 to all affected customers. The letter identified the affected product, problem and the actions to be taken to avoid or minimize the occurrence of the issue. Customers were advised to follow the instruction for Use and that Philips plans to replace the old hook with one that has a new design. For questions contact your local Philips representative 1-800-722-9377.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQB
- Quantity affected
- 536 units
- Distribution
- Worldwide Distribution - US Nationwide and the countries of :Australia, Austria, Bahrain, Belgium, Canada, Chile, China, Czech Republic, Denmark, Finland, , France, Germany, Ireland, Italy, Japan, Net
- Date initiated
- 2012-09-12
- Date posted
- 2012-09-28
- Date terminated
- 2013-07-26
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BUCKY VISION (K982795) | Philips Medical Systems, Inc. | 1998-11-24 |