Philips Diagnost 94, Diagnost 96, Diagnost 97 Universal X-Ray System The Diagnost is a multifunctional, universal X~ray
FDA device recall Z-2765-2011 · posted 2011-07-08 · Terminated
Recall details
- Recalling firm
- Philips Healthcare Inc.
- Reason for recall
- Updated Instructions For Use: During an examination where the patient is positioned on a -rotatable- chair with knees pointed to the rear of the system, the patients lower legs or ankles may be injured/broken
- Action taken
- Philips Healthcare notified accounts by letter on April 18, 2011. The letter advised users of the problem and provided updated instructions for proper placement of the patient during the examination. An Updated Instruction For Use was provided. For further information and support customers were instructed to contact the Philips representative.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 52 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-04-18
- Date posted
- 2011-07-08
- Date terminated
- 2013-02-15
- Location
- Andover, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS DIAGNOST 96 (K912470) | Philips Medical Systems, Inc. | 1991-08-07 |