GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular)
This recall has been terminated (originally issued June 5, 2007).
- Company
- General Electric Med Systems Llc
- Recall Initiated
- March 26, 2007
- Posted
- June 5, 2007
- Terminated
- October 21, 2008
- Recall Number
- Z-0871-2007
- Quantity
- 35
- Firm Location
- Waukesha, WI
- Official Source
- View on FDA website ↗
Reason for Recall
Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control room) or in-room InnovaCentral/Touch-Screen
Distribution
Worldwide Distribution: USA states including-AZ,CA,CO,DE,FL,GA,IL,IN, MD,MN,MO,NJ,NV,NY,OH,OK,OR,PA,SC,SD,TX, UT, VA,WA,WI, and countries of Canada, Belgium, China, Czech Republic, Finland, France, Germany, Hungary, India, Isreal, Italy, Japan, Korea, New Zealand, Norway, Russia, Spain, and United Kingdom.
Lot / Code Info
83016862101656 00060VAS02 00192VAS04 00282VAS02 00371VAS01 01065VAS01 082416070006 082416130024 212305CATH1 416480INNOVA 516562INNOVA6 516562INNOVA7 604682INNOVA1 604682INNOVA2 718470EP 770HMCCL1 781340IN3 83016102100795 83016242100936 83016802100516 83016802100866 83016802100916 83016802101197 83016862101656 83016862101916 858554INNOVA2 A4166952 A5164510 cee15663 HU1205VA01 M2068110 M2569315 M4198195 YV0061 YV0071
Root Cause
Other
Action Taken
A letter dated Jan. 18, 2007, was sent to consignees describing the problem, product ,safety instructions and contact information. Software upgrades were promised for correction.