Recall Z-2770-2015— Lumenis
Class II · Terminated
Class II FDA medical device recall by Lumenis, initiated 2015-07-30, terminated 2018-05-25. It names one FDA 510(k) clearance: K133272. Product: Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System 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: There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue..
- Recalling firm
- Lumenis
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-07-30
- Terminated
- 2018-05-25
- 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
Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System 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
There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.
Data sourced from openFDA. This site is unofficial and independent of the FDA.