Millenium MPS gamma cameras recalled over risk of detector falling
GE HealthCare is recalling 54 Millenium MPS gamma cameras because systems past guaranteed service may have been moved without adequate detector support, risking a detector fall.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: the firm states a detector fall could cause life-threatening bodily injury, and no injuries are reported.
Plain-English summary
Millenium MPS dual-head nuclear medicine gamma cameras, designed specifically for cardiac imaging, are being recalled.
GE HealthCare has become aware that certain nuclear medicine systems past the End of Guaranteed Service could have been transported or relocated without adequate detector support. That could apply excessive stress to the detector mounting mechanisms and compromise their integrity. If that occurs, the firm states it can potentially result in a detector fall and lead to life-threatening bodily injury.
The recall covers 54 units across all serial numbers in distribution, distributed worldwide. The FDA has classified the action as Class II.
The enforcement record describes the failure mode and reports no injuries. Sites operating these systems should follow GE HealthCare's instructions.
The recalled product
- Product
- Millenium MPS; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging
- Manufacturer
- GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- Category
- Medical Device — Nuclear imaging
- Affected units
- 54
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all serial numbers in distribution
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 14 recalled by GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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