CLASS II Device recall · Reported 8 Aug 2018 · FDA Enforcement Report

Somatom Perspective 16 recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Somatom Perspective 16 (, distributed nationwide in the US. The recall was initiated on 1 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial No. 87559 87579 87532 87539 87563 87565 87560 87555 87556 87553 87554 87526 87567 87561 87589 87569 87535 87525 87548 87541 87558 87533 87537 87522 87542 87534 87549 87546 87584 87574 87552 87600 87577 87571 87528 87540 87594 87544

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2475-2018
FDA event ID: 79665
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 1 Feb 2018
FDA classified: 28 Jul 2018
Reported: 8 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

1 Feb 2018	Recall initiated by company
28 Jul 2018	Classified by FDA	+177 days
8 Aug 2018	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

A potential risk of unnecessary radiation exposure due to a software issue

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SOMATOM Perspective 16 (Model 10891666)

Where it was distributed

Nationwide

Questions about this recall

Is Somatom Perspective 16 ( recalled?

Yes. Siemens Medical Solutions USA recalled Somatom Perspective 16 ( on 1 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-2475-2018.

Why was it recalled?

A potential risk of unnecessary radiation exposure due to a software issue

Which lots are affected?

Serial No. 87559 87579 87532 87539 87563 87565 87560 87555 87556 87553 87554 87526 87567 87561 87589 87569 87535 87525 87548 87541 87558 87533 87537 87522 87542 87534 87549 87546 87584 87574 87552 87600 87577 87571 87528 87540 87594 87544

Where was it sold?

Nationwide

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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