Lumenis VersaCut+ Tissue Morcellator Hand Pieces Recalled for Unpredictable Operation
Lumenis is recalling VersaCut+ Tissue Morcellator hand pieces because they may operate unpredictably during surgery, potentially damaging non-target tissue.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (damage to non-target tissue) during a surgical procedure, which aligns with the 'Severe' criteria for significant injury reports or high-risk medical device defects.
Plain-English summary
Lumenis is recalling 54 VersaCut+ Tissue Morcellator devices, which include 108 hand pieces, due to a potential safety issue. The affected components are the hand pieces for the GA-0007500 (Inverted H/P) and GA-0007600 (Regular H/P) systems, specifically identified by codes SA4769200 and SA4768700. The recall covers units distributed worldwide, including in the United States (California, Pennsylvania, Massachusetts, Florida, and New York) and internationally in countries such as Italy, Germany, Australia, China, Great Britain, the United Kingdom, Taiwan, France, Peru, Mexico, Turkey, Spain, and Russia.
The recall is being conducted because there is a probability that the hand pieces may operate inconsistently and unpredictably during the morcellation procedure. This malfunction could result in damage to non-target tissue. 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.
This is an FDA Class II recall. Healthcare providers and facilities that have these devices should stop using the affected hand pieces and contact Lumenis for further instructions on the recall process.
The recalled product
- 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…
- Manufacturer
- Lumenis
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- SA4768700 regular HP) are affected by this recall.
Distribution
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