Recall Z-2353-2015— Trumpf Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Trumpf Medical Systems, Inc., initiated 2015-07-27, terminated 2017-05-03. It names one FDA 510(k) clearance: K061317. Product: Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. 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..
- Recalling firm
- Trumpf Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-27
- Terminated
- 2017-05-03
- Firm location
- Charleston, SC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Trumpf Ceiling Mounted Surgical Lighting Systems,iLED 3/5, User Manual #1558932. 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 for recall
Complaints received of the front joint of the spring arm AC 2000 could break at the interface to the monitor.
Data sourced from openFDA. This site is unofficial and independent of the FDA.