GE Healthcare - Giraffe and Panda iRes Infant Warmer Product Usage: The infant radiant warmers provide infrared heat in

FDA device recall Z-1072-2014 · posted 2014-02-25 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.

Action taken

GE Healthcare sent an Urgent Medical Device Correction letter dated November 18, 2013, with a return receipt to all affected customers. The letter identified the products, the problem, and safety instructions to be taken by the customer along with the product correction. It is recommended that all potential users in your facility are made aware of this safety notification and the recommended actions. Safety issues described the description and affected product details, safety instructions, photos showing the back of the resuscitation system where the Air and Oxygen fittings are located and an appendix of the Affected Product Serial Number Definition and Configurations of Fittings. For questions or concerns regarding this notification, please call the phone number listed below: United States: 1-800-345-2700.

Root cause

Component design/selection

Status

Terminated

Product code

BTL

Quantity affected

12, 373 units total, 8,807 = US, 3,394 = OUS, 172 = unknown

Distribution

Worldwide Distribution - USA Nationwide including the states of AK, 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, NM, NV, NY, O

Date initiated

2013-10-01

Date posted

2014-02-25

Date terminated

2016-07-22

Location

Waukesha, WI

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