Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with softwar

FDA device recall Z-0293-2012 · posted 2011-11-28 · Terminated

Recall details

Recalling firm

Philips Medical Systems (Cleveland) Inc

Reason for recall

The firm determined that during scanning procedures, for some larger patients, some reddening of the skin of can occur in certain instances due to RF heating when the torso of the patient is positioned within the body coil.

Action taken

Philips Medical Systems ( Cleveland) Inc. sent a Urgent Field Safety Notice dated August 3, 2011, to all affected customers. Philips Field Service Engineers were dispatched to the affected customer sites to deliver the recall notification and to perform the necessary software corrections. The letter lists the affected MRI systems; describes the problem; the actions to be taken by the customer/user; it also informs the customer of the upcoming software correction which will be applied to each unit by the Philips Field Service Engineers in order to address this issue. If any additional information is required, the customer is instructed to contact their local Philips Field Service Engineer. For further questions please call Customer Care Solutions Center (CCSC) at 800-722-9377.

Root cause

Software design

Status

Terminated

Product code

LNH

Quantity affected

26 units - 12 units distributed in U.S. & 16 distributed to foreign customers

Distribution

Worldwide Distribution -- USA (nationwide) including the states of AL, AZ, CA, GA, OR, MI, NJ and TX., and the countries of AU, BE, CH, DE, FR, JP, NL and SE.

Date initiated

2011-08-03

Date posted

2011-11-28

Date terminated

2013-02-22

Location

Cleveland, OH

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