HGE Healthcare Patient Monitor B30, Procare Monitor B20, Procare Monitor B40, and Monitor B40 K122253 (Procare Monitor B

FDA device recall Z-0489-2014 · posted 2013-12-12 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of a potential safety issue due to ECG filter settings associated with the B20/B40 V1, B30 and B40 V2 Patient Monitors. The B20, B30 and B40 Patient Monitors set the ECG filter setting incorrectly if the monitor starts with impedance respiration set in the ON position. Instead of the user selected filter, an additional 0.5 Hz high pass filter is used. The

Action taken

GE Healthcare sent an Urgent Medical Device Correction letter dated October 10, 2013, to all affected consignees. The letter described the safety Issue, Safety Instructions, Affected Product, Details, Product Correction and Contact Information (Technical Support at 1-800-558-7044).Consignees were asked to retain a copy of the instructions with the user manual. For questions regarding this recall call 262-513-4122.

Root cause

Software design

Status

Terminated

Product code

MHX

Quantity affected

16,061 (343 US, 15,718 OUS)

Distribution

Worldwide Distribution - USA (nationwide) to CA, CT, FL, GA, MO, NC, NJ, PA, TX, WI and Internationally to: FRANCE, PORTUGAL, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGL

Date initiated

2013-10-11

Date posted

2013-12-12

Date terminated

2016-02-03

Location

Waukesha, WI

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