GE Healthcare, DASH 3000, 4000, 5000 Patient Monitors The Dash 3000/4000/5000 patient monitor is intended for use under

FDA device recall Z-3075-2011 · posted 2011-08-25 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of an issue with the Dash 3000/4000/5000 patient monitors configured with the 802.11b wireless LAN option that may impact patient safety. The Dash monitor may exhibit reboots on some networks when the 802.11b wireless LAN option is used to connect to the hospital wireless LAN infrastructure. This reboot results in a loss of patient monitoring for approxima

Action taken

GE Healthcare sent an URGENT MEDICAL DEVICE CORRECTION letter dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. GE recommended actions that should be taken by a qualified service representative. For any questions regarding the medical device correction or identification of affected items contact Technical Support at 1-800-558-7044 or customers should contact their local Service Representative. UPDATE: A second letter dated 12/13/11 was sent on 1/20/12 to consignees. The revised letter provides an update to the safety instructions and product correction.

Root cause

Software design

Status

Terminated

Product code

MHX

Quantity affected

8029 devices

Distribution

Worldwide Distribution - USA including AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MI, MN, MS, MO, MT, NE, NV, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, W

Date initiated

2011-07-05

Date posted

2011-08-25

Date terminated

2012-09-11

Location

Waukesha, WI

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