Stryker Recalls Ceiling Mounted Surgical Light Systems Due to Fall Risk
Stryker is recalling 1,415 Berchtold Chromophare Ceiling Mounted Surgical Light Systems because a missing snap ring or spanner nut may cause the light to fall.
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 source text explicitly states that the falling light may potentially cause serious injuries, which aligns with the rubric criterion for a score of 4 (Severe) involving significant injury reports or potential.
Plain-English summary
Stryker Communications is recalling 1,415 Berchtold Chromophare Ceiling Mounted Surgical Light Systems, Catalog #CH13000000. The recall affects units with serial numbers ranging from 091316 70016 through 083117-73252. These products were distributed nationwide in the United States and in Canada.
The recall was initiated because the firm became aware that a missing snap ring or spanner nut may result in insufficient mount force. This defect could cause the surgical light to fall from its suspension. If the light falls, it may potentially cause serious injuries to health care providers and/or patients.
Health care providers should stop using the affected surgical lights and contact Stryker Communications for instructions on how to resolve the issue.
The recalled product
- Product
- Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
- Manufacturer
- Stryker Communications
- Affected units
- 1,415
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 Number Range: 091316 70016 through 083117-73252
Distribution
Distributed nationwide across the United States.
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