GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM. The device is a general purpose ultrasound s

FDA device recall Z-1833-2013 · posted 2013-07-31 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could cause the system to freeze. This is an intermittent behavior that also requires a certain workflow. This issue can be resolved by rebooting the system.

Action taken

No consignee letter was sent out. Starting on July 13, 2012, Field Engineers visited consignees and carried on instructions as per Field Modification Instruction (FMI 79044A). The Engineer returned the system to the customer and ensure acceptance. Before leaving the customer site have the staff operate the system. Ensure that: all settings are customized, all peripherals are functioning and all communications are working properly. We plan to update the software on all of the affected GE VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM that were distributed. As an effectiveness check, we will track all service requests for the field action to completion. These service requests will record the repair of the affected units. Exceptions to completion of the service request will be recorded as well. Records of field action completion will be retained per our processes and procedures. Further questions please call 262-513-4122.

Root cause

Software design

Status

Terminated

Product code

IYN

Quantity affected

375

Distribution

Worldwide Distribution - US Distribution including the states AK, AZ, AR, CA, CO, CT, DE, FL, GA, IL, LA, MD, MI, MN, MO, NE, NV, NM, NY, NC, OH, OR, PA, SC, SD, TN,TX, VA, WA and WI., and the countri

Date initiated

2012-07-13

Date posted

2013-07-31

Date terminated

2014-11-10

Location

Waukesha, WI

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