Steris Surgical Lighting Monitor Spring Arms Recalled for Welding Defect
Steris Corporation is recalling 68 vertical spring arms for surgical lighting systems because the welded seam may crack or break.
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 in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Steris Corporation is recalling 68 units of the Vertical Spring Arm for Single or Dual Monitor Mount, used with Harmony LL 500 and Harmony LL 700 surgical lighting systems. The affected model numbers are YG19051 and YG19262.
The recall was issued because the welded seam in the affected monitor spring arms has the potential to crack and/or break. The products were distributed to the United States (Massachusetts, New York, Ohio, Pennsylvania, and Texas) and Canada.
No specific consumer action instructions are provided in the source text. Affected units are identified by specific serial numbers listed in the recall documentation.
The recalled product
- Product
- Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harmony LL 700 surgical lighting systems), Steris Corporation. Model numbers YG19051 and YG19262.
- Manufacturer
- Steris Corporation
- Hazard
- Affected units
- 68
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 (20)
- Model #: YG19051
- Serial #'s: 01108340587
- 01117338881
- 011106337516
- 011106337525
- 011106337527
- 011106337534
- 011106337535
- 011106337538
- 011106337539
- 011106337541
- 011106337626
- 011107338878
- 011107338882
- 011107338883
- 011108340587
- 011108340600
- 0111073388883 & 011108340600A. Model #: YG19262
- Serial #: ART00001 - ART00010
- CADS0001 - CADS0015
Distribution
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