PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units), P1028888-001 PSU (used in Zebra LP2824 Plus printers) PSUs with the following date code; 0639XX through 1253XX (YYWWXX, where YY=Year, and WW=week).
FDA Recall Z-1793-2020 · Posted None
Advertisement
Recalling FirmbioMerieux, Inc.
Recall StatusTerminated
Date Initiated2020-01-24
Date Terminated2023-01-11
Reason for Recall
The recall has been initiated due to potential for overheating or a fire hazard associated with the Zebra LP2824 Plus printer PSU (power supply unit) located within the PREVI Isola instrument.
Firm Action
The firm initiated the recall by letter on 01/15/2020. The Urgent Product Correction Notice instructed the customer the to provide the letter to all appropriate personnel within their organization. The letter instructs the personnel to check their inventory against the serial numbers listed in Appendix A of the letter. The letter also details that a bioMerieux Field Service Engineer will be contacting the customer to schedule a service appointment and if necessary, replace the PSU.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution. US nationwide including AU, BE, CH, DE, ES, FR, IT, HK/CN; MX, NL, RU, SE/FI, ZA.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement