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Health Canada Medical devices

BIOGRAPH LSO 16 SLICE PET

Issued November 26, 2021
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
Hazard description
Revised instructions for use
Product
Product name
BIOGRAPH LSO 16 SLICE PET
Reference
ID
RA-63652