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Biograph mct

Official notice

26 Nov 2021

Last checked

26 Nov 2021

Medium riskHealth Canada

An official Health Canada notice concerns Biograph mct. 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 Published 2021-11-26.

What to do now

Contact the manufacturer if you require additional information.

Recall number

63651

Official notice

2021-11-26

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

63651

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Affected products

Product 1

Affected Products - BIOGRAPH MCT-S WITH TRUE V (64), Lot or serial number - 11030, Model or catalog number - 10248672

Product 2

Affected Products - BIOGRAPH MCT-S (40), Lot or serial number - 60029, Model or catalog number - 10248668

Product 3

Affected Products - BIOGRAPH MCT-S WITH TRUE V (40), Lot or serial number - 11058 11069 60036, Model or catalog number - 10248671

Product 4

Affected Products - BIOGRAPH MCT FLOW-3R, Lot or serial number - 59002, Model or catalog number - 10528956

Product 5

Affected Products - BIOGRAPH MCT FLOW-4R, Lot or serial number - 11002 11010 60036, Model or catalog number - 10529159 10529161

Product 6

Affected Products - BIOGRAPH MCT FLOW EDGE-4R, Lot or serial number - 11013, Model or catalog number - 10528955

Product 7

Affected Products - BIOGRAPH MCT-S (20), Lot or serial number - 91147, Model or catalog number - 10534160

Product 8

Affected Products - BIOGRAPH HORIZON - 3R, Lot or serial number - 94759, Model or catalog number - 10532746

Product 9

Affected Products - BIOGRAPH VISION, Lot or serial number - 11032 11038 11042 11044 11048 11064 11079, Model or catalog number - 10749670 10749672

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Siemens, Biograph Mct.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

63651

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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