Arjo Flat Dynamic Positioning System (2020-10-06)

Starting date:
October 6, 2020
Posting date:
October 16, 2020
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74123

Last updated:

Affected Products

Arjo Flat Dynamic Positioning System

Reason

A number of customer complaints on sling clips breakage when used with Arjo Flat Dynamic Positioning System (DPS). Results of an investigation undertaken into the issue reveal that the continued use of the obsoleted Arjo Flat DPS might lead to complete sling clip breakage and subsequently to its detachment from the DPS attachment point. Note that the product was discontinued (no longer produced and supplied) in 2006 and all the units distributed to the market have already exceeded their life span.

Affected products

Arjo Flat Dynamic Positioning System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

KTS0010
KTX01440
LBA1030
LBX05420
LBX1033
LCA80563
LCA81695

Companies
Manufacturer
ArjoHuntleigh AB
Hans Michelsensgatan 10
Malmo
21120
SWEDEN