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Health product recall

ArjoHuntleigh Sara 3000, Sara Plus, Tenor, Minstrel (2017-10-31)

Starting date:
October 31, 2017
Posting date:
November 30, 2017
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-65266

Affected products

A. SARA PLUS STANDING AID

B. TENOR MOBILE LIFT

C. MINSTREL PATIENT LIFT

D. SARA 3000 PATIENT LIFT

Reason

It has been found that the Sara 3000, Sara plus, Minstrel and Tenor devices have experienced problems with the electrical functions related to the printed circuit board (PCB) losing the safe working load (SWL) settings, resulting in the inconvenience of the device usage. ArjoHuntleigh has decided to perform a PCB software upgrade to eliminate the detected problem.

Affected products

A. SARA PLUS STANDING AID

 

Lot or serial number

Lots manufactured between 12.10.2016 - 31.08.2017

Model or catalog number

HEPXXXX

Companies
Manufacturer

ArjoHuntleigh AB

Hans Michelsensgatan 10

Malmo

21120

SWEDEN



B. TENOR MOBILE LIFT

 

Lot or serial number

Lots manufactured between 03.08.2016 - 31.08.2017

Model or catalog number

KHAXXX

Companies
Manufacturer

ArjoHuntleigh AB

Hans Michelsensgatan 10

Malmo

21120

SWEDEN



C. MINSTREL PATIENT LIFT

 

Lot or serial number

Lots manufactured between  12.09.2016 - 31.08.2017

Model or catalog number

HMAXXX

Companies
Manufacturer

ArjoHuntleigh AB

Hans Michelsensgatan 10

Malmo

21120

SWEDEN



D. SARA 3000 PATIENT LIFT

Lot or serial number

Lots manufactured between  31.05.2016 - 31.08.2017

Model or catalog number

HEAXXXX

Companies
Manufacturer

ArjoHuntleigh AB

Hans Michelsensgatan 10

Malmo

21120

SWEDEN