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:
2020-10-15
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