Device product

Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)

Z-0590-2024

November 20, 2023

Class II

Product summary

Firm: LEICA BIOSYSTEMS NUSSLOCH GMBH
Event: Event 93467
Status: Ongoing
Classification: Class II
Quantity: 98 devices
Official record key: device-enforcement:Z-0590-2024

Official wording

Reason: There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.

Code information: All devices with serial number: G0061-G0701

Distribution pattern: US, Nationwide

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.