The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for
FDA device recall Z-0795-2013 · posted 2013-02-14 · Terminated
Recall details
- Recalling firm
- Lumenis 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.
- Action taken
- Lumenis sent an Urgent Safety Advisory Notice letter dated January 2, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to re-label the devices with the enclosed labels provided, replace the Operation Manual with the current revised Manual, complete the information requested on the Confirmation Card and return the Confirmation Card using the enclosed pre-paid shipping label by UPS. For question contact VersaCut Morcellator field correction administrator by either Cell: +972-(54)-9599196, Tel: +972-(4)-9599296 or E-mail: VersaCutMorcellator@lumenis.com.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 931 units
- Distribution
- Worldwide Distribution - US Nationwide including: CA, WI, NC, FL, PA, IN, NM, NJ, IA, WA, OH, FL, MD, MA, WY, NY, AZ, NH, MN, TN, OK, KY, TX, AK, MI, VT. Internationally: Japan, Nepal, India, UK, Sout
- Date initiated
- 2013-01-02
- Date posted
- 2013-02-14
- Date terminated
- 2013-05-20
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM (K050639) | Lumenis, Inc. | 2005-03-31 |