FDA Enforcement Class II Ongoing

IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. 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: Z-2510-2024 · Reported August 14, 2024

Enforcement

Recall Number: Z-2510-2024
Event ID: 94919
Classification: Class II
Status: Ongoing
Product Type: Devices
Firm: Philips North America Llc
Voluntary / Mandated: Voluntary: Firm initiated
Initial Notification: Letter
Report Date: August 14, 2024
Initiation Date: June 28, 2024
Classification Date: August 5, 2024
Address: 222 Jacobs St, Cambridge, MA, 02141-2289, United States

Description

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> Mmonitors 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,

Code Info

UDI: 00884838038776

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

Quantity

18 units