The Recall Desk
HighFDA (Devices)·Z-0657-2013·Announced 2013-01-16

Stryker Recalls Surgical Light Spring Arms Due to Potential Separation Risk

Stryker is recalling specific surgical light spring arms because a circlip may not engage fully, causing the arm to fall. No serious injuries have been reported.

What this means for you

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 risk-of-harm product (falling equipment) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Stryker Communications, Inc. is recalling specific Spring Arm components used in Visum Halogen Surgical Lights, Visum LED Surgical Lights, and Stryker Flat Panel and Navigation Arms. The recall involves replacement parts that may have been serviced incorrectly, leading to a low likelihood of incomplete engagement of the Spring Arm Circlip.

If the circlip is not fully seated, the Spring Arm could separate and fall, potentially dropping the surgical lights or monitors mounted to it. The affected units were distributed nationwide in the United States and internationally to Australia, Japan, Taiwan, Canada, the United Kingdom, France, the Netherlands, Spain, Mexico, India, Korea, Singapore, New Zealand, Hong Kong, the Philippines, and Brazil.

To date, there have been no serious injuries reported from this issue. Stryker is conducting this field action to address the potential safety hazard associated with the incomplete engagement of the circlip during service or replacement.

The recalled product

Product
(l) Visum Halogen Surgical Light, (2) Visum LED Surgical Light, (3) Stryker Flat Panel and Navigation Arm The Spring Arm Circlip is part of the Stryker Spring Arm used in multiple configurations as a component of the (1)Visum Halogen Surgical Light, (2)Visum LED Surgical Ligh
Manufacturer
Stryker Communications, Inc.
Category
Medical Device — Surgical Lighting
Hazard

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)

  • Code Number and Product Name: 0682000112-SPRING ARM
  • LIGHT 12-18KG
  • 0682000211 - FLAT PANEL SPRING ARM
  • ONDAL SUSPENSION
  • 15-21KG
  • 0682000212 - FLAT PANEL SPRING ARM
  • ONDAL SUSP.
  • 12-18KG
  • 0682000226 - SPRING ARM
  • 3.5-7KG
  • NAVIGATION
  • 0682000228 - SPRING ARM
  • LIGHT 9-15KG
  • 0682001062 - PKG EDS LIGHT SUSPENSION CENTRAL AXIS 5P/FP
  • 0682001270 - 9-POLE SPRING ARM
  • AC 2000
  • 15-21 KG
  • 0682001274 - 5-POLE SPRING ARM AC 2000 15-21 KG
  • 0682400034 - FLAT PANEL SPRING ARM
  • EDS SUSPENSION

Distribution

Distributed nationwide across the United States.

Related recalls

Same hazard · falling object

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