Trumpf Ceiling Mounted Surgical Lighting Systems Recalled for Joint Breakage Risk
Trumpf Medical Systems is recalling 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 involves a medical device with a structural defect that could cause injury, but the source text does not report any actual injuries or illnesses, 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 its Ceiling Mounted Surgical Lighting Systems, including the TruVidia HD model. The recall involves 9,287 units distributed worldwide, including the United States and numerous international markets.
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 presents a potential risk of injury if the component fails while in use.
Healthcare facilities and users of these surgical lighting systems should stop using the affected units and contact Trumpf Medical Systems for further instructions on corrective actions.
The recalled product
- Product
- Trumpf Ceiling Mounted Surgical Lighting Systems,TruVidia HD, User Manual #1513140. 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.
- 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.
See all 5 products in this recall →Related recalls
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Similar recalls
- HighTrumpf Ceiling Mounted Surgical Light Systems Recalled for Falling Hazard
FDA (Devices) · 2016-01-06
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