Recall Z-2311-2012— Trumpf Medical Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Trumpf Medical Systems, Inc., initiated 2012-05-29, terminated 2013-04-11. It names one FDA 510(k) clearance: K061317. Product: Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.. Reason: Cracks can arise on the welded seam on the rear joint..
- Recalling firm
- Trumpf Medical Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-05-29
- Terminated
- 2013-04-11
- 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
Acrobat 3000 (AC3000) Spring Arm as support arm for iLED operating lights, TRUMPF Medizinsysteme GmbH + Co KG 82178 Puchheim. The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light.
Reason for recall
Cracks can arise on the welded seam on the rear joint.
Data sourced from openFDA. This site is unofficial and independent of the FDA.