FDA Medical Device Recalls (openFDA)
General Electric Med Systems LLC: GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular)
- Recall number
- Z-0871-2007
- Recalling firm
- General Electric Med Systems LLC
- Product
- GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and vascular)
- Status
- Terminated
- Initiated
- 2007-03-26
- Posted
- 2007-06-05
- Terminated
- 2008-10-21
- Reason
- 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
- Root cause
- Other
- Action
- 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.
- Quantity
- 35
- 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, serial or model codes
- 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
- 510(k) numbers
- ["K023178","K031637","K042053","K050489","K052157","K052412"]
- PMA numbers
- not on file
- Product code
- MQB
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28