GE The CARESCAPE Monitor B850 includes both new and existing subsystems interconnected to form a high acuity, multi-para

FDA device recall Z-1929-2011 · posted 2011-04-08 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has become aware of potential safety issues associated with the CARESCAPE" Monitor B850 when Patient Data Module (PDM), Tram Acquisition Module (Tram), Patient Side Module (E-PSM or E-PSMP), E- MASIMO or E-(P)RE(S)TN modules or Bed-to-bed alarming feature is used. 1. When CARESCAPE Monitor B850 is used with the above listed modules, some SpO2 alarms may be delayed or missed. 2. Whe

Action taken

The firm, GE Healthcare, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated February 25, 2011 to its consignees/customers. The letter was addressed to Healthcare Administrator / Risk Manager, Chief of Nursing, and Director of Biomedical Engineering. The letter described the recall product the problem, Safety Issues, Affected Product details, Product Correction, Safety Instructions and Contact Information. The customers were instructed to follow the safety instructions provided in the letter. GE Healthcare is working on a software correction that will be provided to their customers once it is available. If you have any questions regarding this medical device correction or the identification or affected items please contact Technical Support at 1-800-558-7044, or your local Service Representative.

Root cause

Software design

Status

Terminated

Product code

MHX

Quantity affected

3817

Distribution

Worldwide distribution: USA including states of:AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA,WA, WI, and WV; a

Date initiated

2011-03-08

Date posted

2011-04-08

Date terminated

2012-06-05

Location

Waukesha, WI

Related 510(k) clearances