05

Aug

2024

FDA Recall: Incorrect or Delayed Patient Treatment May Result from Incorrect Updated Software Options

0

Company: Philips North America Llc
Date of Enforcement Report: 8/5/2024
Class II

PRODUCT

IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866060. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and neonates.

Recall Number:

Z-2508-2024

REASON:

Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software Options. Changes were made to reflect some options becoming standard capabilities for software-version N.x. In the process, the entitlements of software options MOS, M06, and M20 were removed for software versions L.x and M.x. As a result of these changes Patient Monitors manufactured with or updated to the latest versions of software L.x or M.x will not offer the capabilities> Monitors with software version K.x may experience this issue too, due to software version K being out of support and the devices being provided with L.x entitlements offered by software options MOS, M06, and M20. Potential for incorrect or delayed treatment for the patient.

RECALLING FIRM/MANUFACTURER:

Philips North America Llc

VOLUME OF PRODUCT IN COMMERCE:

4 units

DISTRIBUTION:

Nationwide Foreign: Australia Austria Bangladesh Brazil Canada Chile China Colombia Denmark France Germany Hong Kong India Indonesia Italy Japan Netherlands Portugal Singapore South Africa South Korea Spain Sri Lanka Sweden Switzerland Taiwan Thailand United Kingdom Vietnam

About the author

Allison Pate

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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