Recall Z-2660-2017 ยท IEO Processor, Tissue, Automated
Leica Microsystems, Inc.
Nussloch GmbH ASP6025 Tissue Processor
| Date | Jun 19, 2017 |
| Status | Open, Classified |
| Reason | Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. |
| Root cause | Labeling mix-ups |
| Action | Customers were notified via email on 06/19/2017. Instructions to customers included to clean surface around the Alarm Connectors and place the newly provided label at the Alarm Connectors (over the engraved specification). They were also instructed to update their current Instructions For Use and update the online help function in the software, as well as return the response form. |
| Quantity | 812 units |
| Distribution | Domestic: AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV, & DC. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, England, France, Georgia, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.