CLASS II Device recall · Reported 26 Mar 2014 · FDA Enforcement Report

syngo Dynamics Picture Archiving and Communication System (PACS) recalled

Siemens Medical Solutions USA is recalling syngo Dynamics Picture Archiving and Communication System (PACS), distributed nationwide in the US. The recall was initiated on 27 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration.

Quantity recalled50

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-1216-2014
FDA event ID: 67559
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 27 Jan 2014
FDA classified: 18 Mar 2014
Reported: 26 Mar 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

27 Jan 2014	Recall initiated by company
18 Mar 2014	Classified by FDA	+50 days
26 Mar 2014	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

Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673

Where it was distributed

Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA.

Nationwide Arkansas California Connecticut Georgia Iowa Illinois Indiana Kansas Massachusetts Michigan Minnesota Missouri New Jersey New York Ohio Oregon Pennsylvania Tennessee Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

Model nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration.

Where was it sold?

Nationwide distribution to MN, AR, MA, TX, NJ, WV, GA, CA, PA, OH, MI, WI, TN, NY, KS, CT, NY, MO, IL, IN, OR, IA, and WA.

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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