The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2311-2012·Announced 2012-09-12

Trumpf Acrobat 3000 Spring Arm Recalled for Welded Seam Cracks

Trumpf Medical Systems is recalling Acrobat 3000 spring arms for iLED operating lights because cracks can form on the welded seam at the rear joint.

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 used in operating rooms. While no injuries are reported, the potential for the arm to fail during a procedure presents a risk of harm, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Trumpf Medical Systems, Inc. is recalling the Acrobat 3000 (AC3000) Spring Arm, which serves as a support arm for iLED operating lights. These surgical lights are intended to locally illuminate an operating or examination area of a patient's body with high-intensity light.

The recall is being conducted because cracks can arise on the welded seam on the rear joint of the spring arm. A total of 402 units are affected by this recall.

The affected units were distributed worldwide, including in the United States (California, Ohio, Oklahoma, New York, Pennsylvania, Texas, and Wyoming) and Canada. Consumers and healthcare facilities should stop using the affected spring arms and contact the recalling firm for instructions on replacement or repair.

The recalled product

Product
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
Manufacturer
Trumpf Medical Systems, Inc.
Category
Medical Device — Surgical Lighting
Hazard
Affected units
402

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 (18)

  • I.D. on nameplate: FA AC3 or FA AC3000
  • Material #1920632
  • Serial #011201602557 to 011201602588
  • Serial #011203602617 to 011202602621
  • Serial #011203602676 to 011203602695
  • Serial #011203602756 to 011203602775
  • Serial #011203602776 to 011203602795
  • Serial #011204602798 to 011204602817
  • Serial #011204602861 to 011204602880
  • Serial #011204602970 to 011204602989
  • Serial #011205603032 to 011205603081
  • Serial #011206603118 to 011206603167
  • Serial #011206603168 to 011206603217
  • Serial #011207603303 to 011207603314
  • Serial #011208603316 to 011205603333
  • Serial #011208603361 - Serial #011209603431 to 011209603462
  • Serial #011210603572 to 011210603597 and Material #1851710
  • Serial #3705776 to 3705777 and Serial #4105778 to 4105781.

Distribution

Distributed in 7 states:

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