Mammography systems recalled over a missing or incorrect X-ray warning label
GE Medical Systems is recalling 1,818 Senographe Pristina mammography systems because some have a missing or incorrect X-Ray Warning label.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 under the documentation criterion: the record cites a missing or incorrect warning label with no product defect or reported harm.
Plain-English summary
The GE Senographe Pristina, Pristina Serena and Pristina Serena 3D systems, used for screening and diagnostic mammography, are being recalled.
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which the firm states is a nonconformance to FDA regulation 21 CFR 1020.30(j).
The record lists 1,818 units, of which 1,580 are in the United States and 238 outside it, across GTINs including 00840682118460, 00840682142052, 00840682145879 and 00195278022745. Distribution was in the United States and outside it. The FDA has classified the action as Class II.
The record describes a missing or incorrect warning label rather than a defect in the system itself, and states no injuries. Facilities should follow GE's instructions.
The recalled product
- Product
- Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
- Manufacturer
- GE Medical Systems, LLC
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)
- GTINs: 00840682118460
- 00840682142052
- 00840682145879
- 00195278022745
- 00195278276971
- 00195278661999
- 00195278665379
- 00195278914026
Distribution
Distribution scope not specified by the agency.
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