Health product recall

BIOGRAPH LSO 16 SLICE PET

Last updated

Summary

Product
BIOGRAPH LSO 16 SLICE PET
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 LSO 16 SLICE PET

48450

87 28 581

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

810 INNOVATION DRIVE, KNOXVILLE,

TENNESSEE, UNITED STATES 

37932

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63652