Datascope recalls CS100 IABP devices with software version Q.01 due to outdated battery specifications in instructions. Owners should check their device details and contact Datascope for updates.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Datascope is recalling CS100 IABP devices with software version Q.01 because the battery runtime and cycle specifications in the instructions need updating. This could lead to incorrect battery usage if not corrected.
The battery specifications in the device's instructions are outdated. If not updated, users might misinterpret battery life or cycles, potentially leading to incorrect usage.
Patients using CS100 IABP devices with software version Q.01 are most at risk. Healthcare providers who own these devices may need to update the instructions.
Check for the product name 'CS100 IABP' and software version 'Q.01' on the device. All models, serial numbers, and UDI codes are affected.
Identify the software version on your CS100 IABP device to confirm if it's Q.01.
Reach out to Datascope for instructions on updating the battery specifications in the device's instructions.
No, the recall does not require immediate discontinuation. The issue is about updating instructions, not a safety hazard requiring immediate action.
The recall applies to all devices with software version Q.01. If your device has a different version, it is not affected.
Datascope will provide updated instructions for the battery specifications. Contact them directly for details.
We’ve drafted a message you can send Datascope to request your refund or repair — edit it as you like.
Subject: Recall Z-1486-2026 — Datascope Datascope Hello, I own a Datascope that is covered by recall Z-1486-2026 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.
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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.
