GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On-

FDA device recall Z-1147-2014 · posted 2014-03-06 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of a potential safety issue with the Solar 8000M/i Patient Monitor Automatic-View-On-Alarm (AVOA) feature. The Solar 8000M/i AVOA feature will stop functioning if the patient monitor is discharged from the CIC Central Station while a remote automatic bedside alarm view is currently being displayed on the Solar. Once this issue occurs, subsequent remote AV

Action taken

GE Healthcare sent a "Urgent Medical Device Correction" letter dated February 12, 2014. The letter was sent to all affected customers. It identified the product the problem and the action needed to be taken by the customers. This issue affects all Solar 8000M/i Patient Monitors running software version 5.4, 5.5, or 5.6 with the Automatic-View-On-Alarm (AVOA) feature enabled. GE Healthcare will provide a correction at no charge once it is available. We will contact you to arrange for this correction. 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

10,211 (7,549 units US, 2,662 units OUS)

Distribution

Worldwide Distribution - USA (nationwide) including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, GA, ID, IL, IN, KS, KY, LA, ME, MD, MA, MI, MN, NS, NO, NE, NH, NH, NM, NY, NC, OH, OK, OR, PA, SC

Date initiated

2014-02-13

Date posted

2014-03-06

Date terminated

2015-07-10

Location

Waukesha, WI

Related 510(k) clearances