Multi-parameter command modules may produce inaccurate cardiac output readings

Plain-English summary

The Multi-parameter Command Module, model 91496, optioned with Masimo or Nellcor, is being recalled. The action covers 1,790 units.

The module has a circuit board issue. When in Auto mode, cardiac output measurement may activate early, resulting in a Bad Curve error with no cardiac output measurement, or an Irregular Curve error where the cardiac output measurement is not automatically excluded. According to the manufacturer this may result in inaccurate readings or the need for additional readings, which may lead to delayed care and/or fluid overload. The FDA classified the action as Class II.

Distribution was worldwide, including nationwide in the United States across states including New York, New Jersey, Alabama, Oklahoma, Iowa, Montana, Wyoming, Minnesota, Texas, Wisconsin and Pennsylvania. The modules are used in hospital monitoring rather than sold to consumers.

Facilities should identify affected units using the serial numbers and UDI codes in the recall notice and follow the instructions issued by the manufacturer.

The recalled product

Product

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

Manufacturer

Spacelabs Healthcare, Inc.

Category

Medical Device — Patient monitoring module

Hazard

• inaccurate-readings
• cardiac-output
• circuit-board-fault
• class-ii
• delayed-care

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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