Datascope recalls Cardiosave Hybrid models with specific serial numbers due to outdated vibration and shock table standards in the user manual. Affected units require IFU addendum for correct standards.
The IFU addendum updates the Vibration and Shock Table to reference the correct standards.
Datascope is recalling several Cardiosave Hybrid models because the user manual references outdated vibration and shock table standards. This means the device may not meet current safety requirements without the updated instructions.
The recall involves outdated standards in the vibration and shock table section of the user manual. This could lead to incorrect usage if the device is not properly aligned with current safety requirements.
Users of Cardiosave Hybrid models with the listed serial numbers and model codes are affected. Most at risk are healthcare professionals using the device for cardiac monitoring.
Check for model numbers 0998-00-0800-31 to 0998-UC-0800-55 with all serial numbers. The recall covers specific units identified by the UDI-DI and serial numbers listed in the notice.
Check if your Cardiosave Hybrid model has the updated IFU addendum for vibration and shock table standards.
The recall is due to outdated vibration and shock table standards in the user manual that need updating to meet current safety requirements.
No, but you must ensure your device has the updated IFU addendum for correct standards.
Check your model number against the list of 15 specific models provided in the recall notice.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-0931-2026 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-0931-2026 from Datascope. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
