GE Healthcare, Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems. K060259: The Innova 3131IQ (3131-IQ) a

FDA device recall Z-2376-2012 · posted 2012-09-13 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of a potential safety issue with respect to the Innova 2121IQ & Innova 3131IQ Systems. While performing a fluoroscopic acquisition with the Innova 2121IQ or Innova 3131IQ systems, there is a potential for loss of usable imaging mode which requires the system to restart in order to recover.

Action taken

GE Healthcare sent an Urgent Medical Device Correction letter dated August 16, 2012, to all affected consignees. The letter described the Safety Issue, safety Instructions, Affected Product Details, Product Correction, and Contact Information. Consignees were instructed that hospital staff should wait for Photo or Image to appear on the display (when store photo function is performed) before start of the next short duration fluoroscopy acquisition. For questions customers were instructed to call: United States (800) 437-1171 Japan: 0120 - 055 - 919 For other countries consignees should contact their local GE Healthcare Service Representative. For questions regarding this recall call 262-513-4122.

Root cause

Software design

Status

Terminated

Product code

MQB

Quantity affected

240 (133 US and 107 OUS)

Distribution

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, FL, HI, IK, IL IN, IA, KS, LA, MD, MA, MI, MN,MO, NV, NH, NH, NM, NY, NC, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, and WI,.and internationally

Date initiated

2012-08-16

Date posted

2012-09-13

Date terminated

2015-10-20

Location

Waukesha, WI

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