Recall Z-1826-2014— Philips Medical Systems, Inc.

Name: FDA recall Z-1826-2014
Creator: U.S. Food and Drug Administration
Published: 2014-05-15

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-05-15, terminated 2015-08-07. It names one FDA 510(k) clearance: K110151. Product: Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.. Reason: Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-05-15
Terminated: 2015-08-07
Firm location: Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K110151 — ACHIEVA R4 1.5T AND ACHIEVA R4 3.0TPhilips Health Care·cleared 2011-03-22

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 MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia 1.5T & 3.0T products) Product Usage: Diagnostic MR System. The Height Adjustable FlexTrak trolley and Trolley Variable Height IRF is an optional device designed to prepare the patient outside the examination room to enhance workflow and make additional non-magnetic hospital beds unnecessary.

Reason for recall

Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.

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