Health product recall

Berchtold Chromophare Ceiling Mounted Surgical Light System (2019-08-09)

Starting date:
August 9, 2019
Posting date:
August 23, 2019
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-70789

Last updated: 2019-08-23

Affected Products

Berchtold Chromophare Ceiling Mounted Surgical Light System

Reason

Stryker had become aware that there was a remote likelihood that the Berchtold Chromophare DFP monitor mounts may have an insufficient weld. Stryker was made aware of this issue via customer complaint PI#1520823 submitted May 1 2017. PFA 1579712 was originally opened to address this issue [Health Canada Incident # 153729]. This PFA was completed and closed January 18, 2019. As of August 1st Stryker Comm has become aware that the original scope excluded 3 units sold to Canada.

Affected products

Berchtold Chromophare Ceiling Mounted Surgical Light System

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

CT 0605004

Companies
Manufacturer

Stryker Communications

1410 Lakeside Pkwy #100

Flower Mound

75028

Texas

UNITED STATES