Stryker Recalls Berchtold Chromophare Monitor Carrier Arms Due to Weld Defects
Stryker Communications is recalling 52 Berchtold Chromophare Dual Monitor Carrier Arms or Dual Flat Panels because the mounts may have insufficient welds.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural defects in medical devices.
Plain-English summary
Stryker Communications is recalling 52 units of the Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, which are components of the Berchtold Chromophare Ceiling Mounted Surgical Light System. The recall was initiated because the mounts on the monitor may have an insufficient weld.
The affected devices have serial numbers ranging from DFP-075-0307-0001 to DFP-075-1014-0230. Distribution was made to 21 U.S. states, including California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, and Wisconsin. The devices were also distributed to Canada and Germany. There was no government or military distribution.
This is an FDA Class II recall. Users should contact Stryker Communications for further instructions regarding the replacement or repair of the affected components.
The recalled product
- Product
- Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
- Manufacturer
- Stryker Communications
- Affected units
- 52
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230.
Distribution
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