AD6 table for use with Integris and Integris Allura x-ray systems. The AD6 is the tilt version.
FDA device recall Z-0207-06 · posted 2005-11-29 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Potential for high voltage exposure involving the injector interface connector of patient support tables.
- Action taken
- On 10/10/05 the firm issued a letter to customers alerting customers to the problem and advising that the firm will perform an upgrade to the devices at customer sites. In March 2006 the firm issued a second notification letter involving more units.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZI
- Quantity affected
- 529 units with MD6 tablets
- Distribution
- Devices were distributed nationwide to hospitals/medical centers.
- Date initiated
- 2005-10-12
- Date posted
- 2005-11-29
- Date terminated
- 2011-03-09
- Location
- Bothell, WA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2 (K031333) | Philips Medical Systems North America, Inc. | 2003-05-13 |
| PHILIPS INTEGRIS ALLURA 9 WITH FD OPTION (K020055) | Philips Medical Systems | 2002-03-15 |
| PHILIPS INTEGRIS ALLURA (K002016) | Philips Medical Systems North America, Inc. | 2000-09-06 |
| RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000) SYSTEMS (K984545) | Philips Medical Systems North America, Inc. | 1999-02-25 |
| PHILIPS INTEGRIS H/HM SYSTEM (K925302) | Philips Medical Systems, Inc. | 1992-12-17 |