Thermoflect Blankets and product line - Recall: Products are not to be used in MR environment

[FDA MedWatch <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Thermoflect Blankets and product line - Recall: Products are not to be used in MR environment

Thermoflect Blankets and product line - Recall

Audience: Radiological healthcare professionals, hospital risk managers

Encompass Group and FDA notified healthcare professionals of the voluntary recall of the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment. FDA has recommended that the Thermoflect blankets and other products not be used in MR conditional or MR compatible environments. Encompass is in the process of sending labels to customers to be attached per instructions to remind hospitals that the product line should not be used in the MR environment. A complete list of Thermoflect products and additional information can be found at www.thermoflect.com.

Read the complete MedWatch 2009 Safety summary, including a link to the firm press release, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm195703.htm

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