Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported October 12, 2022
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
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 i…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips North America Llc recalled MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a compon… - a moderate-severity action.
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a compon… was recalled by Philips North America Llc in October 12, 2022. Reason: Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disc…. Check the official notice for the remedy. Verify recall #Z-0004-2023 with the FDA Devices before acting.
The recall
Philips North America Llc issued this moderate-severity FDA Devices recall-Device may intermittently fail to produce audio. Turning the unit off and on does not resolve the issue; disc….
- Moderate
- severity level
- Class II
- classification
- October 12, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0004-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0004-2023) was formally reported on October 12, 2022, with the manufacturer initiating the action on September 6, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Philips North America Llc is listed as the recalling firm, operating out of Cambridge, MA. Federal records list the affected scope as 115 US; 193 ROW.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Domestic distribution to AL AZ CA CO FL GA ID IL IN LA MA MI MN NC NE NJ OH PA SC TN TX UT VT WA WY. Foreign distribution to Australia Austria Belgium Czech Republic Denmark Estonia Finland France Germany Ireland Italy…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
115 US; 193 ROW
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0004-2023 |
| Date reported | October 12, 2022 |
| Date initiated | September 6, 2022 |
| Recalling firm | Philips North America Llc |
| Firm location | Cambridge, MA |
| Affected scope | 115 US; 193 ROW |
| Distribution | Domestic distribution to AL AZ CA CO FL GA ID IL IN LA MA MI MN NC NE NJ OH PA SC TN TX UT VT WA WY. Foreign distribution to Australia Austria Belgium Czech Republic Denmark Estonia Finland France Germany Ireland Italy Malta Netherlands N… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0004-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.. Recalled by Philips North America Llc. Units affected: 115 US; 193 ROW.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 12, 2022. Severity: Moderate. Recall number: Z-0004-2023.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution to AL AZ CA CO FL GA ID IL IN LA MA MI MN NC NE NJ OH PA SC TN TX UT VT WA WY. Foreign distribution to Australia Austria Belgium Czech Republic Denmark Estonia Finland France Germany Ireland Italy Malta Netherlands Norway Poland Portugal Qatar Singapore Slovakia Spain Sweden Switzerland United Kingdom.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0004-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 12, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.