Trumpf Ceiling Mounted Surgical Lighting Systems Recalled Due to Spring Arm Defect
Trumpf Medical Systems is recalling 9,287 ceiling-mounted surgical lighting systems because the front joint of the spring arm may break at the monitor interface.
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 is classified as FDA Class II, and the source text describes a mechanical defect (joint breakage) in a medical device without reporting specific injuries or hospitalizations, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Trumpf Medical Systems, Inc. is recalling 9,287 units of its Ceiling Mounted Surgical Lighting Systems, specifically the Helion and Xenion S/M/L models. These devices are intended to locally illuminate an operating or examination area of a patient's body with high-intensity light.
The recall was initiated due to complaints that the front joint of the spring arm AC 2000 could break at the interface to the monitor. This defect poses a risk of the component failing during use. The affected units were distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous other countries.
Healthcare facilities and consumers should stop using the affected surgical lighting systems and contact Trumpf Medical Systems for instructions on how to proceed with the recall. The specific material numbers associated with the recalled units are listed in the official FDA recall record Z-2355-2015.
The recalled product
- Product
- Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light.
- Manufacturer
- Trumpf Medical Systems, Inc.
- Hazard
- Affected units
- 9,287
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)
- Description: Federarm 3kg
- 3 polig (Swing)
- 0376289
- Federarm 12-18kg
- 5-polig Kamera eco
- 0376290
- Federarm TFT Stop AC 2000
- 9-15kg
- 0376291
- Federarm TFT Stop AC 3000
- 12-18kg
- 0376292
- Federarm TFT Stop Space bis 30kg
- 0376293
- Federarm 3-polig NRH
- 0376294
- Federarm 5-polig NRH
- 0376295
- Federarm 3-polig NRH gerader Abgang
- 0376296
Distribution
Part of a larger recall action
This product is one of 5 recalled by Trumpf Medical Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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