Nimbus 4 & Nimbus Professional mattresses (2021-04-13)

Starting date:
April 13, 2021
Posting date:
April 29, 2021
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-75493

Last updated:

Affected Products 

  1. NIMBUS 4 MATTRESS
  2. NIMBUS PROFESSIONAL MATTRESS

Reason

Customer complaint on over-inflation (abnormal inflation issue) occurring during the product installation, preparation to initiate therapy or product use. In none of those events, any injury or health consequences were reported. The products in the market have been recognized as potentially affected with the risk of abnormal inflation which might result in the mattress surface raised above its specification. The investigation revealed that the failure is caused by damage of inner mattress tubes.

Affected products

A. NIMBUS 4 MATTRESS

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

650001DAR

Companies
Manufacturer
ArjoHuntleigh AB
Hans Michelsensgatan 10
Malmo
21120
SWEDEN

B. NIMBUS PROFESSIONAL MATTRESS

Lot or serial number

More than 10 numbers, contact manufacturer. 

Model or catalog number

651001P

Companies
Manufacturer
ArjoHuntleigh AB
Hans Michelsensgatan 10
Malmo
21120
SWEDEN