GE Healthcare GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. Cardiovascular Imaging System.
Brand
GE Healthcare
Lot Codes / Batch Numbers
all serial numbers
Products Sold
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GE Healthcare is recalling GE Medical Systems Innova 2000 and Innova 2000S, and Innova 2000 and Innova 2000S mobile version. C due to Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect screws were used for mounting the detector which may lead to a possible part falling onto a patient.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026