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: 2021-11-26
Alert / recall type
Health product recall
Category
Health product » Medical device » 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