The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-2446-2019·Announced 2019-09-11

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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Category
Medical Device — Surgical Lighting Components
Hazard
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

Distributed in 21 states:

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