Health product recall

BIOGRAPH MCT

Last updated

Summary

Product
BIOGRAPH MCT
Issue
Medical devices - Revised instructions for use
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
BIOGRAPH MCT-S WITH TRUE V (64) 11030 10248672
BIOGRAPH MCT-S (40) 60029 10248668
BIOGRAPH MCT-S WITH TRUE V (40) 11058 11069 60036 10248671
BIOGRAPH MCT FLOW-3R 59002 10528956
BIOGRAPH MCT FLOW-4R 11002 11010 60036 10529159 10529161
BIOGRAPH MCT FLOW EDGE-4R 11013 10528955
BIOGRAPH MCT-S (20) 91147 10534160
BIOGRAPH HORIZON - 3R 94759 10532746
BIOGRAPH VISION 11032 11038 11042 11044 11048 11064 11079 10749670 10749672

Issue

There is potential patient fall hazards could occur when the PHS pallet/foot extension is improperly assembled by the operator. PHS pallet/foot extension patient fall hazards could occur when the extension is improperly used to position the patient head-first. The pallet/foot extension should only be used for positioning the patient's feet. To avoid this issue, customers are advised to ensure proper operator assembly of the PHS pallet/foot extension as instructed in the operator's manual and as depicted on the extension label. And to only use the PHS pallet/foot extension for its intended purpose of feet first imaging as instructed in the operator's manual. The operator manual cautions of the improper use of the positioning aids and notes to only use the intended purpose. The foot extension itself is labelled and instructions of proper use of extension are also provided.

 

Recall start date: 2021-11-08

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

SIEMENS MEDICAL SOLUTIONS USA, INC. MOLECULAR IMAGING

2501 NORTH BARRINGTON ROAD, HOFFMAN ESTATES

ILLINOIS, UNITED STATES
60192

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63651

Get notified

Receive notifications for new and updated recalls and alerts by category.

Subscribe