CLASS II Device recall · Reported 13 Apr 2016 · FDA Enforcement Report

A Picture Archiving and Communication System recalled

Siemens Medical Solutions USA is recalling A Picture Archiving and Communication System (PACS) intended to display, process, read, distributed nationwide in the US. The recall was initiated on 18 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel # 10014063

Quantity recalled49 imaging systems

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-1349-2016
FDA event ID: 73475
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 18 Jan 2016
FDA classified: 7 Apr 2016
Reported: 13 Apr 2016
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

18 Jan 2016	Recall initiated by company
7 Apr 2016	Classified by FDA	+80 days
13 Apr 2016	Published in enforcement report	+6 days

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

Reason for recall

To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.

Product as listed by the FDA

A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images, including digital mammography images.

Where it was distributed

US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.

Nationwide Alabama California Colorado Connecticut Florida Iowa Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi North Carolina Nebraska New Jersey New York Oklahoma

Questions about this recall

Why was it recalled?

To inform users about the possible incorrect values for Distance Measurements when using certain modalities in combination with syngo Imaging.

Which lots are affected?

Model # 10014063

Where was it sold?

US (nationwide) including the states of AL, CA, CO, CT, FL, IA, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OK, OR, PA, TN, TX, and WI.

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.

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