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IntelliVue Patient Monitor MX400 with L.x and M.x recallZ-2508-2024 · Philips North America Llc · initiated Jun 28, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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,

FDA root cause category: Software design

What the company is doing

Philips North America issued URGENT Medical Device Correction on 6/25/24 to End-Users. Philips Market Organizations will distribute the letters outside of the U.S. Letter states reason for recall, health risk and action to take: Use only default measurement capabilities, as indicated in Table 1 above, for monitoring purposes. Pass this notice to all those who need to be aware within your organization or to any organization where affected devices have been potentially transferred. A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will reload the current device software to enable missing options (MOS, M06, M20). If you need any further information, please contact your local Philips representative or call 1-800-722-9377.

Recall details

Recall number
Z-2508-2024
Status
Open, Classified
Initiated by the company
Jun 28, 2024
Posted by the FDA
Aug 5, 2024
Recalling firm
Philips North America Llc
Quantity
4 units
Product code
MHX
FDA submissions
K130849
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

Product description

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.

Code information (models, lots, serial numbers)

UDI: 00884838038752

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94919).

Sources and updates

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