Spacelabs Healthcare 91496 Multi-parameter Module Recall Affects 1,790 Units Worldwide (2026)

How to identify if yours is affected

1. Locate the model 91496 and check if the Masimo or Nellcor option is present.
2. Review serial numbers and UDI-DI as listed in the recall documents.
3. Verify the device was distributed worldwide including US states listed in the recall.

Where to find product info

Check the FDA recall page and manufacturer notification letter for exact serials and identifiers.

What timeline to expect

Refunds or replacements will follow the manufacturer’s recall process, timelines not specified.

If the manufacturer is unresponsive

• Document all communications with the manufacturer.
• File a formal complaint with CP SC if unresponsive.
• Consider seeking legal counsel for injury-related or significant delays.

How to prevent similar issues

• Ensure future devices have robust Auto mode validation for cardiac output.
• Track recalls via FDA and manufacturer notices.
• Avoid using recalled medical devices in clinical decision making until cleared.

Documentation advice

Keep recall letter, serial numbers, and communication logs.