CLASS II Device recall · Reported 10 Jul 2019 · FDA Enforcement Report

Somatom go.Up recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Somatom go.Up (, distributed nationwide in the US. The recall was initiated on 28 May 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Number: 112552 112551 112555 112519 112542 112545 112541 112536 112573

Quantity recalled9

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-1915-2019
FDA event ID: 83081
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 28 May 2019
FDA classified: 2 Jul 2019
Reported: 10 Jul 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

28 May 2019	Recall initiated by company
2 Jul 2019	Classified by FDA	+35 days
10 Jul 2019	Published in enforcement report	+8 days

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

Reason for recall

The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.

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 go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.

Where it was distributed

US Nationwide distributed in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and Puerto Rico.

Nationwide Alaska Alabama Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi

Questions about this recall

Why was it recalled?

The potential sporadic performance problems may result in scanning workflow interruptions and unexpected user notifications. This may cause a delay in diagnosis or patient scans.

Which lots are affected?

Serial Number: 112552 112551 112555 112519 112542 112545 112541 112536 112573

Where was it sold?

US Nationwide distributed in the states of AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, PA, SC, TX, VA, WA, WI, and Puerto Rico.

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

Other products in this recall event

3 other products · FDA event 83081

Reported	Class	Recall	Company	Reason	Where
10 Jul 2019	CLASS II	Somatom go.All recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
10 Jul 2019	CLASS II	Somatom go.Top recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
10 Jul 2019	CLASS II	Somatom go.Now recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide

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