SOMATOM Emotion 16 recall
SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane…
Why was SOMATOM Emotion 16 recalled?
A potential safety issue involving two (2) broken screws and one (1) bowed, which is used to fix the Balance Weight of the DMS in the gantry, was found during a service call at the customer site.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
model numbers: 10165977, with serial numbers: 32310 32254 32322 32317 32303 32295 32327 32309 32319 32237 32326 32259 32323 32257 32298 32315 32268 32244 32252 32293 32349 32313 32334 32301 32339 32277 32292 32281 32273 32320 32324 32346 32270
- Product
- SOMATOM Emotion 16; produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 40 total
- Distribution
- Nationwide Distribution.
- Recall date
- July 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)