Recall Z-0004-2023— Philips North America Llc

Name: FDA recall Z-0004-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-06

Class II · Ongoing

Class II FDA medical device recall by Philips North America Llc, initiated 2022-09-06. It names one FDA 510(k) clearance: K212227. Product: MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.. Reason: Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue..

Recalling firm: Philips North America Llc
Classification: Class II
Status: Ongoing
Initiated: 2022-09-06
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K212227 — Philips MR Patient Care PortalInvivo Corporation·cleared 2021-09-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.

Reason for recall

Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disconnecting and reconnecting to AC power does not reliably resolve the issue.

Data sourced from openFDA. This site is unofficial and independent of the FDA.