GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM) is intended to provide uninterrupted acquisiti

FDA device recall Z-0747-2014 · posted 2014-01-14 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of a potential safety issue due to intermittent failure of the spring loaded mounting latch of PDMs produced from April 2007 through December 2012.

Action taken

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated November 26, 2013 to its consignees/customers. The letter was addressed to Healthcare Administrator / Risk Manger, Chief of Nursing and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The consignees/customers were instructed to please ensure that all potential users in your facility are made aware of this safety notification and the recommended actions. GE Healthcare will provide a new latch at no charge once it is available. GE will contact you to arrange for installation of the latch. If you have any questions regarding this notification, please contact Technical Support at 1-800-558-7044, or your local Service Representative.

Root cause

Device Design

Status

Terminated

Product code

MHX

Quantity affected

43,033 (25,681 USA; 17,352 OUS)

Distribution

Worldwide Distribution: US (nationwide) including states of: AL, AZ, AR, CA, CO, CT, DC, FL, GA, ID, IL, IN, IA, KS,KY, LA, ME, MD, MA, MI, MN, MS, NO, NE, NV, NJ, NM, NY, NC, OH, OK,OR, PA, RI, SC, T

Date initiated

2013-11-27

Date posted

2014-01-14

Date terminated

2016-09-07

Location

Waukesha, WI

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