Recall Z-0795-2013— Lumenis Limited
Class I · Terminated
Class I FDA medical device recall by Lumenis Limited, initiated 2013-01-02, terminated 2013-05-20. It names one FDA 510(k) clearance: K050639. Product: The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.. Reason: Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up..
- Recalling firm
- Lumenis Limited
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2013-01-02
- Terminated
- 2013-05-20
- Firm location
- Yokneam, Israel
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
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
Reason for recall
Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up.
Data sourced from openFDA. This site is unofficial and independent of the FDA.