Agency classClass IIOur severity:High FDA (Devices)·Z-0692-2018·Announced 2018-03-07

Stryker Recalls Berchtold Chromophare Monitor Arms Due to Weld Defects

Stryker Communications is recalling 850 Berchtold Chromophare Dual Monitor Carrier Arms and Flat Panels because the mounts may have missing or incomplete 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect (insufficient weld) in a medical device where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Stryker Communications is recalling 850 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, missing, or incomplete weld.

The affected products were distributed to medical facilities nationwide, including government and military facilities. International distribution included Canada, Belgium, China, the United Kingdom, UAE, France, Germany, Spain, Japan, Ecuador, and Russia. Affected serial numbers for the United States and Canada range from DFP-075-0307-0001 to DFP-075-1014-0230, while international serial numbers range from 6145060-O11628 to 6176090-V14102.

Medical facilities should contact Stryker Communications for instructions on how to resolve the issue. The source text does not report any specific injuries or illnesses associated with this defect.

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: structural-defect
fall-hazard
Affected units: 850

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 (2)

United States and Canada: Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230
International: Serial numbers 6145060-O11628 to 6176090-V14102

Distribution

Distributed nationwide across the United States.

Same manufacturer · Stryker Communications

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