Recall Z-1864-2014— Philips Medical Systems, Inc.

Name: FDA recall Z-1864-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-13

Class II · Terminated

Class II FDA medical device recall by Philips Medical Systems, Inc., initiated 2014-06-13, terminated 2016-01-27. It names one FDA 510(k) clearance: K110151. Product: Ingenia 3.0T, magnetic resonance imaging system.. Reason: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts..

Recalling firm: Philips Medical Systems, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-06-13
Terminated: 2016-01-27
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

Ingenia 3.0T, magnetic resonance imaging system.

Reason for recall

For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.

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