Reported Sep 23, 2015 · Terminated
Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended…
Lumenis
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lumenis · 13 Hayetzira St.,Yokneam Ind. Park · Yokneam · N/A
Is this the product you have?
- 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.
- Lot codes and dates
- GA-0007500 (VersaCut + System with Inverted H/P) and GA-0007600 (VersaCut + System with Regular H/P). Only the hand pieces for the system (SA4769200 inverted HP, SA4768700 regular HP) are affected by this recall.
- Amount recalled
- 54 devices with 108 hand pieces
Where it was sold
Why it was recalled
There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Lumenis recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.