Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense XL Torso coil 12nc on coil: 4535-

FDA device recall Z-2461-2010 · posted 2010-09-22 · Terminated

Recall details

Recalling firm

Philips Medical Systems North America Co. Phillips

Reason for recall

The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient can occur. Especially in combination with high SAR levels and when the RF cables of the coil are too close to the patient, this RF interaction has resulted in RF burns to patients.

Action taken

Philips Healthcare issued URGENT-Device Correction Notices dated September 30, 2008 to their consignees. The notice identified the recalled device as 1.5 Intera and 1.5T Achieva MRI systems, described the risk to patients, and the actions to be taken by customers.. The firm has issued Field Change Order (FCO) 78100242. Field service representatives will visit each consignee and conduct a hardware upgrade, applying a sleeve over the cable that will ensure proper spacing between the cable and patient, reducing the chance of RF interaction and burns. The consignees should contact the Philips Call Center at 1-800-772-9377, #5 #3, #1 and reference "FCO 78100242 - PATIENT CABLE SLEEVE FOR 1.5T SENSE XL TORSO COIL".

Root cause

Other

Status

Terminated

Product code

MOS

Quantity affected

47 units total (Achieva 1.5T and Intera 1.5T)

Distribution

Nationwide Distribution: Throughout USA. No distribution to foreign consignees.

Date initiated

2008-09-30

Date posted

2010-09-22

Date terminated

2010-09-30

Location

Bothell, WA

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