Recalls / —

—#108328

Product

Allura X-ray System. The Allura X-ray System is an angiographic X-ray system.

FDA product code

IZI — System, X-Ray, Angiographic

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K031333, K033737

Affected lot / code info

722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 722001, 722003, 722008

Why it was recalled

The monitor Ceiling suspension may fail, which may cause the monitor to drop.

Root cause (FDA determination)

Process control

Action the firm took

Philips sent an "URGENT-FIELD SAFETY NOTICE" dated March 27, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter provides information for continued safe and proper use of the equipment. Contact your local Philips representative at 866-767-2822 for further support regarding this issue. Recall expanded 5-2013 to additional 460 units distributed worldwide.

Recalling firm

Firm

Philips Healthcare Inc.

Address

3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern

Worldwide Distribution-USA (nationwide) including Puerto Rico and the countries of Algeria, Argentina, Belgium, Brazil, Canada, Czech Rep, Chili, China, Columbia, Denmark, Egypt, France, Germany, India, Indonesia, Italy, Japan, Malaysia, Mexico, Morocco, Netherlands, Oman, Russia, Saudi Arabia, Singapore, South Korea, Spain, Thailand, United Kingdom, and Vietnam.

Timeline

Recall initiated

2012-04-02

Posted by FDA

2012-04-25

Terminated

2014-05-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #108328. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.