SOMATOM Emotion 16, the intended use of computed tomography… recallZ-1645-2015 · Siemens Medical Solutions USA, Inc · initiated Apr 20, 2015
Class II Terminated All recalls posted in May 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Siemens Medical Solutions USA, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Software bugs in VC20B SP0a or SP1 software versions may cause issues that could make it necessary to rescan patients. Syngo Main UI may crash if the Patient Browser is scrolled with arrow keys of the keyboard. Tomo images may freeze on the screen when zoomed in or out under the mode of CAREVision. Sporadic displaying error in WorkStream4D application. DB may lock under heavy and multitasks.
FDA root cause category: Software design
What the company is doing
Siemens sent an Customer Safety Advisory Notice dated April 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A remote software update is scheduled for release that will resolve the issue. For further questions, please call (610) 219-6300.
Recall details
- Recall number
- Z-1645-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 20, 2015
- Posted by the FDA
- May 22, 2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 75
- Product code
- JAK
- FDA submissions
- K133424
- Distribution
- Nationwide Distribution including Puerto Rico.
Product description
SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
Code information (models, lots, serial numbers)
SOMATOM Emotion 16 (2007) 10165977 with serial numbers: 86514 32490 80553 32552 32530 86406 86558 80542 80461 86405 32512 80441 86431 80467 86425 80442 86429 86557 80434 32581 32637 32597 80448 80431 32624 32469 80446 32578 80430
Other devices under the same FDA submission
1 device cleared under K133424 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- SOMATOM Emotion 6-slice configuration 10165888Siemens Shanghai Medical Equipment Ltd. · System, x-ray, tomography, computed1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 71101).
- Z-1644-2015 · TerminatedSOMATOM Emotion 6; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the sa…
- Z-1646-2015 · TerminatedSOMATOM Perspective; the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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