Senographe Pristina recall
Senographe Pristina
Why was Senographe Pristina recalled?
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN(s): 195278022745, 195278276971, 195278628916, 195278661999, 195278665379, 840682118460, 840682142052, 840682145879
- Product
- Senographe Pristina
- Recalling firm
- GE Medical Systems, SCS
- Quantity
- 180 units (60 US; 120 OUS)
- Distribution
- Us Nationwide-Worldwide Distribution
- Recall date
- February 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)