Senographe Pristina X-ray system missing audible exposure termination signal
GE Medical Systems is recalling 180 Senographe Pristina mammography X-ray systems because the audible signal indicating the end of X-ray exposure intermittently fails to sound, violating FDA safety requirements.
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: This is a Class II FDA medical device with a safety control failure affecting radiation exposure monitoring. The intermittent failure of the audible signal is a regulatory violation that could prevent operators from confirming when X-ray exposure has ended. No injuries or illnesses have been reported. This qualifies as a risk-of-harm product in a critical domain (radiation safety) where injury has not yet been reported.
Plain-English summary
GE Medical Systems, SCS is recalling 180 Senographe Pristina diagnostic mammography X-ray systems. The recall affects 60 units distributed in the United States and 120 units distributed outside the United States.
The devices are subject to recall because the audible signal that indicates termination of X-ray exposure intermittently fails to sound. This failure violates FDA safety requirements under 21 CFR 1020.31(j), which mandates that X-ray systems provide an audible signal to inform operators when radiation exposure has ended.
The recalled devices may have been distributed to medical facilities and diagnostic imaging centers. GE Medical Systems recommends that facilities using affected Senographe Pristina systems contact the company immediately. Users should cease operation of the devices until the issue has been resolved through repair, replacement, or other appropriate corrective action issued by GE Medical Systems.
The recalled product
- Product
- Senographe Pristina
- Manufacturer
- GE Medical Systems, SCS
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 (8)
- GTIN(s): 195278022745
- 195278276971
- 195278628916
- 195278661999
- 195278665379
- 840682118460
- 840682142052
- 840682145879
Distribution
Distributed nationwide across the United States.
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