Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applicati
FDA device recall Z-0704-2016 · posted 2016-01-30 · Terminated
Recall details
- Recalling firm
- Philips Electronics North America Corporation
- Reason for recall
- The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
- Action taken
- The firm, Philips, issued "URGENT-Field Safety Notices" dated 10/26/2015 and 11/19/2015 to its customers. The notices described the product, problem and actions to be taken. The customers were instructed to ensure the audible signal (X-ray buzzer) is always enabled, to activate only ONE fluoroscopy pedal at time, and to configure the footswitch to the default Philips configuration. Customers were also instructed to review the information with all members of your staff who need to be aware; retain a copy with the equipment IFU and complete and return the Confirmation Respond form to Mail Stop 4302, 3000 Minuteman Road, Andover, MA 01810 or email: Debra.Gibbs@Philips.com. Philips is tracking the delivery of these notices via certified return receipt. If you need any further information or support concerning this issue, please contact your local Philips representative: Technical Support Line: 1-800-722-9377.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OWB
- Quantity affected
- 13297 in total
- Distribution
- Worldwide Distribution: US (Nationwide) including Puerto Rico and countries of: Albania, Algeria, US Virgin Islands, Argentina, Australia, Austria, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and He
- Date initiated
- 2015-11-03
- Date posted
- 2016-01-30
- Date terminated
- 2020-09-15
- Location
- Andover, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES (K141979) | Philips Medical Systems Netherland BV | 2014-08-19 |