—#209932

Product

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

FDA product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K130849, K131872
Affected lot / code info: IntelliVue Patient Monitor MX400, 866060, UDI-DI: 00884838038752; IntelliVue Patient Monitor MX430, 866061, UDI-DI: 00884838057562; IntelliVue Patient Monitor MX450, 866062, UDI-DI: 00884838038769; IntelliVue Patient Monitor MX500, 866064, UDI-DI: 00884838038776; IntelliVue Patient Monitor MX550, 866066, UDI-DI: 00884838038783; Only MX400-550 devices shipped after 26-April-2024 are affected. Please refer to the manufacturing date on the back of your monitor.

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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

Recalling firm

Firm: Philips North America
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2296

Distribution

Distribution pattern: US Nationwide. Global Distribution.

Timeline

Recall initiated: 2024-08-30
Posted by FDA: 2024-09-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209932. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.