CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: R

FDA device recall Z-1594-2016 · posted 2016-05-02 · Terminated

Recall details

Recalling firm

Carestream Health Inc

Reason for recall

Carestream Health received a complaint related to CARESTREAM Image Suite 4 from a foreign hospital stating that the annotation on the overlay is displayed as "L (Left)", when it should be "R(Right)".

Action taken

Carestream Health sent an URGENT MEDICAL DEVICE CORRECTION letter dated April 6, 2016, and Consignee Notification Acknowledgement form to the US consignees on April 15, 2016, via Certified Mail, Return Receipt Requested. Foreign consignees are being notified based on the individual country regulations. Customers who have this Image Suite configuration but do not use it for CT or MR Imaging do not need to take any action. Customers who use the product for CT or MR Images are asked to make users aware of the problem and take additional steps to check correct orientation of any markers, until the software is updated. Customers with questions or concerns were instructed to contact the Carestream Customer Care Center in the US at 1-800-328-2910. Customers outside the US were instructed to contact their local Service Support number. For questions regarding this recall call 1-800-328-2917.

Root cause

Software design

Status

Terminated

Product code

LLZ

Quantity affected

US: 37 units, Foreign: 269 units

Distribution

NY and OH for further distribution nationwide; Foreign distribution to the following countries: Afghanistan, Angola, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia & Herzgovena, B

Date initiated

2016-04-15

Date posted

2016-05-02

Date terminated

2017-03-16

Location

Rochester, NY

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