Philips BV Pulsera R2.2 Mobile X-ray system. The Type Product Code 718094 can be found under the X-ray trolley cover on
FDA device recall Z-0140-2011 · posted 2010-10-25 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems North America Co. Phillips
- Reason for recall
- Reliability of the Stand-Trolley cable may result in loss of images on the monitor during an examination. This intermittent problem can lead to System lock-up, where no radiation is possible and images are not visible on the monitor
- Action taken
- On 10/04/2008, Philips began sending the URGENT-Device Correction BV Pulsera R2.2 and Endura R2.2 letters to their customers. On 09/03/2008, the firm issued the Field Change Order (FCO) 71800024 and the firm's representative will replace the stand-trolley cable free of charge. Customers should contact Philips Call Center at 1-800-722-9377, #5, #2, and reference "FCO 71800024" with any questions.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- JAA
- Quantity affected
- 1331 units
- Distribution
- Nationwide distribution.
- Date initiated
- 2008-09-05
- Date posted
- 2010-10-25
- Date terminated
- 2010-12-07
- Location
- Bothell, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PHILIPS BV PULSERA/ENDURA (K010435) | Philips Medical Systems, Inc. | 2001-03-12 |