Recall Z-2494-2012— Philips Healthcare Inc.

Name: FDA recall Z-2494-2012
Creator: U.S. Food and Drug Administration
Published: 2012-09-12

Class II · Terminated

Class II FDA medical device recall by Philips Healthcare Inc., initiated 2012-09-12, terminated 2013-07-26. It names one FDA 510(k) clearance: K982795. 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. Reason: Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator.

Recalling firm: Philips Healthcare Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-09-12
Terminated: 2013-07-26
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K982795 — PHILIPS BUCKY VISIONPhilips Medical Systems, Inc.·cleared 1998-11-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.