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

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  Reason
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  Affected products

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