FDAClass IIApril 13, 2016

A Picture Archiving and Communication System recall

A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital…

Why was A Picture Archiving and Communication System recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model # 10014063

Product
A Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital…
Recalling firm
Siemens Medical Solutions USA, Inc
Quantity
49 imaging systems
Distribution
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.
Recall date
April 13, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls