FDA Medical Device Recalls (openFDA)
LEICA BIOSYSTEMS NUSSLOCH GMBH: Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
- Recall number
- Z-0590-2024
- Recalling firm
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Product
- Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
- Status
- Open, Classified
- Initiated
- 2023-11-20
- Posted
- 2023-12-20
- Terminated
- not on file
- 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.
- Root cause
- Other
- Action
- Leica issued an URGENT Medical Device Recall notice to its consignees on 11/20/2023 via email. The notice explained the issue with the device and instructed the consignee to ensure the selection of the correct setting of the carryover value for al created or edited protocols and follow the instructions in the IFU.
- Quantity
- 98 devices
- Distribution
- US, Nationwide
- Lot, serial or model codes
- All devices with serial number: G0061-G0701
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IEO
- Firm FEI
- 3002179321
- Firm city
- Nussloch
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28