Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac tabl

FDA device recall Z-0408-2011 · posted 2010-11-17 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has become aware of a potential issue regarding Innova systems with GE Fluoro UPS 20KVA that may impact patient safety. GE Fluoro UPS 20KVA (Uninterrupted Power Supply) is used to maintain fluoroscopy availability for approximately 5 minutes should there be a main power failure. Once power is restored, the equipment power will be returned to the main hospital power. UPS fluoro ba

Action taken

GE Healthcare sent an "Urgent Medical Device Correction" letter on August 5, 2009 to all Hospital Administrators / Risk Mangers, Mangers of Radiology / Cardiology and Radiologists / Cardiologists. The letter was dated August 4, 2009, and described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. For questions regarding this recall call (262) 548-2731.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MQB

Quantity affected

222

Distribution

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

Date initiated

2009-08-05

Date posted

2010-11-17

Date terminated

2014-01-16

Location

Waukesha, WI

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