FDA Medical Device Recalls (openFDA)
GE Healthcare: GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System.
- Recall number
- Z-0896-06
- Recalling firm
- GE Healthcare
- Product
- GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System.
- Status
- Terminated
- Initiated
- 2006-03-06
- Posted
- 2006-05-24
- Terminated
- 2008-02-24
- Reason
- Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.
- Root cause
- Other
- Action
- GEHC is issuing a validated field action 3/6/2006 to correct the issues. Existing screws/bolts will be replaced using correct torque with screws containing cotter pins. Loctite liquid glue will be applied. Service manuals have been updated with instructions for using correct screws and torque. The field action is being implemented via Field Modification Instruction (FMI) 12033.
- Quantity
- 856 (534 domestic and 322 OUS)
- Distribution
- Nationwide including Puerto Rico and OUS to include: Australia, Belgium, Brazil, Bulgaria, Byelarus, Canada, China, Columbia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Greece, Honduras, Hungary, Indonesia, Iraq, Ireland, Israel, India, Iran, Italy, Jordan, Japan, Republic of Korea, Lebanon, Lithuania, Martinique, Mexico, Morocco, Netherlands, Norway, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Republic of China, Thailand, Tunisia, Turkey, United Kingdom, Venezuela
- Lot, serial or model codes
- all serial numbers
- 510(k) numbers
- ["K022322","K024200"]
- 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