Trumpf Ceiling Mounted Surgical Lighting Systems Recalled for Spring Arm Defect
Trumpf Medical Systems is recalling TruLight 3000/5000 surgical lights because the front joint of the spring arm could 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 hazard involves a structural component that could break, posing a risk of harm to patients or staff, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Trumpf Medical Systems, Inc. is recalling 9,287 units of Trumpf Ceiling Mounted Surgical Lighting Systems, TruLight 3000/5000. The recall is due to complaints that the front joint of the spring arm AC 2000 could break at the interface to the monitor.
The affected products are intended to locally illuminate an operating or examination area of the patient's body with a high intensity light. The recall covers units distributed worldwide, including the United States (nationwide) and Puerto Rico, as well as numerous other countries.
Consumers and healthcare facilities should stop using the affected surgical lighting systems and contact Trumpf Medical Systems, Inc. for further instructions on the recall.
The recalled product
- Product
- Trumpf Ceiling Mounted Surgical Lighting Systems,TruLight 3000/5000, User Manual #1528403. 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.
See all 5 products in this recall →Related recalls
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