—#104996

Product

Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction. This MRI system is indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities. Image appearance is determined by the spatial distribution and flow as well as by many different NMR related properties of the tissue and anatomy studied and the MRI scan technique applied. These images and/or spectra, when interpreted by a trained physician, provide information that may assist the diagnosis.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K110151
Affected lot / code info: Twelve (12) units were distributed to customers in the U.S. The recalled Serial Numbers are: 42001, 42003, 41000, 41005, 42006, 42040, 41035, 41028, 42034, 42033, 41034 and 42038.

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2011-08-03
Posted by FDA: 2011-11-28
Terminated: 2013-02-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #104996. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.