Recalls / —

—#112761

Product

Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System

FDA product code

MQB — Solid State X-Ray Imager (Flat Panel/Digital Imager)

Device class

Class 2

Medical specialty

Radiology

510(k) numbers

K982795

Affected lot / code info

Serial number range (patient carriage) from:  00 000 00 to 09 000 543.

Why it was recalled

Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator

Root cause (FDA determination)

Device Design

Action the firm took

Philips Healthcare sent an Urgent Field Safety Notice letter dated August 15, 2012 to all affected customers. The letter identified the affected product, problem and the actions to be taken to avoid or minimize the occurrence of the issue. Customers were advised to follow the instruction for Use and that Philips plans to replace the old hook with one that has a new design. For questions contact your local Philips representative 1-800-722-9377.

Recalling firm

Firm

Philips Healthcare Inc.

Address

3000 Minuteman Road, Andover, Massachusetts 01810

Distribution

Distribution pattern

Worldwide Distribution - US Nationwide and the countries of :Australia, Austria, Bahrain, Belgium, Canada, Chile, China, Czech Republic, Denmark, Finland, , France, Germany, Ireland, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Qatar, Romania, Russia, Saudi Arabia, Sweden, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan. Thailand, Turkey,United Arab Emirates and United Kingdom.

Timeline

Recall initiated

2012-09-12

Posted by FDA

2012-09-28

Terminated

2013-07-26

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #112761. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.