INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic

FDA device recall Z-0729-2016 · 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

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