FDA Device recall Z-2355-2015
Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784
- FDA Device
- Class II
- terminated
- Published 2015-08-19
On 2015-08-19 the FDA classified a Class II recall of Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784 by Trumpf Medical Systems, citing complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2355-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-27 |
| Published | 2015-08-19 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Trumpf Medical Systems |
| Distribution | US |
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.
Reason
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
Identifiers
| code_info | The following Material numbers may appear on any of the attached recalled/corrected units: Material #0376288, Descripti…The following Material numbers may appear on any of the attached recalled/corrected units: Material #0376288, 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, Federarm 5-polig NRH gerader Abgang; 0379528, FA AC3000, Stop 7-11KG; 0385719, FA AC 2000 NRH mobil 3p, 12-18kg NG; 1387323, Federarmsicherungssegment AC3000; 1387324, Federarmsicherungssegment AC2000; 1388338, Federarm 12-18 kg 3 polig, HEL2; 1388339, Federarm 12-18 kg 5 polig HEL2; 1388340, Federarm 12-18 kg 9 polig (HELION); 1408906, FA AC2 Stop max 11kg; 1471010, FA AC2000 3p, 12-18kg; 1471011, FA AC2000 Stop 12-18kg; 1471012, FA AC2000 NRH 3p, 12-18kg; 1471013, FA AC2000, 7p, 12-18kg; 1471014, FA AC2000 NRH 7p, 12-18kg; 1471015, FA AC3000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2355-2015%22
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