Health product recall

System 83 (+) Plus (2018-02-27)

Starting date:
February 27, 2018
Posting date:
March 13, 2018
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-66144

Affected products

SYSTEM 83+ (Plus)

Reason

As of previous safety notifications, Custom Ultrasonics Inc. revised the labeling of the user manual of the System 83 Plus 2 and the System 83 Plus 9 Washer-Disinfectors.

Affected products

SYSTEM 83+ (Plus)

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

SYSTEM 83 PLUS 2

SYSTEM 83 PLUS 9

 

Companies
Manufacturer

Custom Ultrasonics Inc.

144 Railroad Drive

Ivyland

18974

UNITED STATES