The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and Intera 1.5T MR systems". The Identification of the Synergy Flex-M/ Shoulder Coil 1.5T can be found on the driver box. The 12nc of the affected system is labeled as 4522-131-6656x.
FDA Recall Z-0469-2011 · Posted 2010-11-26
Recalling FirmPhilips Medical Systems North America Co. Phillips
Recall StatusTerminated
Product CodeLNH
Date Initiated2009-05-01
Date Terminated2011-01-06
Product Quantity389 units
Reason for Recall
Combined use of the Synergy Flex-M / Shoulder Coil 1.5T increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient.
Firm Action
Philips issued URGENT-Field Safety Notice letters dated May 1, 2009 and October 14, 2009 to their consignees. The letter informed customers that the firm will replace the "old" Flex M/Shoulder Coils with a new Flex-M coil.
Consignees could contact Philips Healthcare Call Center at 800-722-9377, #5, #3, #1 and reference FCO 78100290 for any questions.
Root Cause
Other
Distribution Pattern
Nationwide Distribution: in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VA, WA, WI, WV, WY, and Washington DC. There were no foreign consignees.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.