IntelliVue Patient Monitor MX400 (Model Number 866060)… recallZ-3249-2024 · Philips North America · initiated Aug 30, 2024

Why it was recalled

During a production process, Philips became aware of one IntelliVue power supply with a broken ground bolt upon disconnection of the ground cable from the equipotential ground connector. Loss of electrical grounding may negatively affect the devices electromagnetic immunity and emission.

FDA root cause category: Nonconforming Material/Component

What the company is doing

An URGENT Medical Device Correction notification letter dated 8/30/24 was sent to customers. Actions that should be taken by the customer / user to prevent risks for patients or users " Please check if the equipotential connector is broken off (refer to Figure 1). If yes, remove the device from use. " 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. " Customers should complete the URGENT Medical Device Response Form either via the QR code below or at the end of the notification to submit both their acknowledgment of this recall and confirm understanding of actions to be taken. If hard copy of Response Form is completed in lieu of digital version (via QR code) please return to Philips at recall.responsephilips.com. You may also fax it to 877 499 7223. Actions planned by Philips to correct the problem A Philips representative will contact you to schedule a visit from a Philips Field Service Engineer who will replace the power supply. If you need any further information, please contact your local Philips representative, or call 1-800-722-9377. Distributors: Philips is requesting customers to return a Response Form to acknowledge receipt and understanding of the URGENT Medical Device Correction and confirm that the information from this Letter has been properly distributed to all users that handle the affected product. Together with this letter we are providing a list of affected products that Philips has sold to your organization. As distributor of the affected products, we kindly request that you: o Add in the Response Form attached your contact information. o Send the attached URGENT Medical Device Correction to each customer to whom you have distributed any affected product as soon as possible and no later than three days, together with the Reply Card. o Perform a good faith effort to get the Reply Form by following up with the customer with a minimum of t

Recall details

Recall number

Z-3249-2024

Status

Open, Classified

Initiated by the company

Aug 30, 2024

Posted by the FDA

Sep 25, 2024

Recalling firm

Philips North America

Quantity

545 devices

Product code

MHX

FDA submissions

K130849, K131872

Distribution

US Nationwide. Global Distribution.

Product description

IntelliVue Patient Monitor MX400 (Model Number 866060), MX430 (Model Number 866061), MX450 (Model Number 866062), MX500 (Model Number 866064), and MX550 (Model Number 866066)

Devices named in this recall

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

• IntelliVue MX450 Patient Monitor IntelliVue Patient Monitor MX450

  Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  5 recalls22 deaths320 reports
• IntelliVue MX550 Patient Monitor IntelliVue Patient Monitor MX550

  Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  5 recalls12 deaths256 reports
• IntelliVue MX500 Patient Monitor IntelliVue Patient Monitor MX500

  Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  5 recalls6 deaths133 reports
• IntelliVue MX400 Patient Monitor IntelliVue Patient Monitor MX400

  Philips Medizin Systeme Böblingen GmbH · MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)
  4 recalls6 deaths93 reports