Z-0413-06

GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact cardiac-optimized nuclear imaging...

Name: Z-0413-06 GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact cardiac-optimized nuclear imaging...
Creator: GE Healthcare
Published: 2005-04-18
License: https://open.fda.gov/license/

GE Healthcare / initiated 2005-04-18 / Terminated

FDA source

GE Healthcare began a recall of GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact cardiac-optimized nuclear imaging system. It is comprised of 2 digital CSE (Correlated... on 2005-04-18. The reason FDA records is "In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0413-06
Status: Terminated
Initiated: 2005-04-18
Posted: 2006-01-24
Terminated: 2008-02-24
Recalling firm: GE Healthcare
Product: GE Millennium Systems: MC, MyoSight. Dual Head Gamma Camera. A compact cardiac-optimized nuclear imaging system. It is comprised of 2 digital CSE (Correlated Signal Enhancement) detectors in variable geometries mounted on a pass-through ring gantry, a compact imaging table, and a GENIE Acquisition station.
Product code: KPS System, Tomography, Computed, Emission
Reason for recall: In certain cases, one of the four collimator locking mechanisms that attach the collimator to the head may work itself free if collimator exchange has not been performed for an extended period of time. This situation, if neglected, could eventually cause the locking mechanism to unlock itself.
FDA root cause: Other
Action: Customer letter is being sent to all customers who have an affected system. The letter alerts customers of the potential release of the locking mechanism and requires a Weekly Collimator Exchange Procedure to avoid release of the locking latch until the permanent solution is made available.
Quantity in commerce: 1421 total for all affected Millenium Systems
Distribution: nationwide including Puerto Rico, and to countries including: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Denmark, Egypt, France, Germany, Iceland, India, Israel, Italy, Jordan, Korea, Kuwait, Luxembourg, Martinique, Mexico, New Zealand, Philippines Romania, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Taiwan and United Kingdom.
Product codes and lots: all serial numbers

Product code KPS

K962738Class IIMillennium Mt and Millennium Mg Nuclear Medicine SystemsGE Medical Systems / cleared 1996-10-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)