Health product recall

Synapse PACS Versions 5.7.200 (2021-04-27)

Starting date:
April 27, 2021
Posting date:
May 20, 2021
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-75621

Last updated:
2021-05-20

Affected Products 

Synapse PACS Versions 5.7.200

Reason

Christie Innomed was informed by the manufacturer of a new problem regarding Synapse PACS 5.7.200. In very rare occasions, the wrong patient information may be displayed in the viewer or PowerJacket. This may be seen in the following scenarios:                                          A. When opening studies from the All Patients folder;                                                                                                                                        B. Rapidly switching between patients (opening studies for different patients);
C. In the event of a silent script error that freezes the PowerJacket. Additionally, for studies from a Siemens Modality for PET and CT, Incorrect Max Standard Uptake Values (SUV) may be returned.

Affected products

Synapse PACS Versions 5.7.200

Lot or serial number

Software Versions 5.1& higher

Model or catalog number

SYNAPSE PACS

Companies
Manufacturer

Fujifilm Medical Systems USA

3020 Carrington Mill Blvd

Morrisville

27560

North Carolina

UNITED STATES