Nuclear medicine systems recalled over inadequate detector support during transport
GE Medical Systems Israel is recalling 38 MAXXUS systems because units past end of guaranteed service may have been moved without adequate detector support, risking a detector fall.
The agency’s classification
FDA (Drugs): 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 compromised mounting could cause a detector fall and life-threatening injury, and no falls or injuries are reported.
Plain-English summary
The MAXXUS emission computed tomography system is being recalled by GE Medical Systems Israel, Functional Imaging.
GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. The firm states this could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity, and that if this occurs it can potentially result in a detector fall and lead to life-threatening bodily injury. The record states there have been no reports of detector falls or injuries as a result of this potential issue, and that the impacted systems have not been manufactured for several years.
The record lists 38 units, covering all serial numbers in distribution. Distribution was in the United States and to Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain, Chile, Germany, Iran and Greece among other countries. The FDA has classified the action as Class II.
Facilities should follow GE HealthCare's instructions.
The recalled product
- Product
- MOTRIN 2'S DISP.- 50CT
- Manufacturer
- GOLD STAR DISTRIBUTION INC
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 lots within expiry distributed by Gold Star Distribution.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 27 recalled by GOLD STAR DISTRIBUTION INC under a single FDA (Drugs) 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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