Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported December 20, 2023
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quenc…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Philips North America Llc recalled Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Phili… - a critical-severity action.
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Phili… was recalled by Philips North America Llc in December 20, 2023. Reason: Firm was informed of an event in which the structural integrity of the MR system components failed due to uni…. Check the official notice for the remedy. Verify recall #Z-0505-2024 with the FDA Devices before acting.
The recall
Philips North America Llc issued this critical-severity FDA Devices recall-Firm was informed of an event in which the structural integrity of the MR system components failed due to uni….
- Critical
- severity level
- Class I
- classification
- December 20, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0505-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0505-2024) was formally reported on December 20, 2023, with the manufacturer initiating the action on November 17, 2023. It is classified under Critical severity (Class I), 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 150 US; 192 ROW.
The documented reason for this recall is: Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain th… Distribution data in the federal record shows the product reached: Domestic distribution to AL AZ CA CO DE FL GA IA IL IN KS KY LA MA MD MI MO NE NJ NV NY OH OK OR PA SC TN TX UT VA VT WA WI WV International distribution to Argentina Austria Canada China Colombia Croatia Czech Republi…. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
150 US; 192 ROW
Related Recalls
6
3 from same agency
Product description
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.
Reason for recall
Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death include chemical exposure (i.e. helium gas) that may expand to surrounding rooms, contusion caused by debris, and asphyxia.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0505-2024 |
| Date reported | December 20, 2023 |
| Date initiated | November 17, 2023 |
| Recalling firm | Philips North America Llc |
| Firm location | Cambridge, MA |
| Affected scope | 150 US; 192 ROW |
| Distribution | Domestic distribution to AL AZ CA CO DE FL GA IA IL IN KS KY LA MA MD MI MO NE NJ NV NY OH OK OR PA SC TN TX UT VA VT WA WI WV International distribution to Argentina Austria Canada China Colombia Croatia Czech Republic Denmark Ecuador Eg… |
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-0505-2024) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) systems are Medical Electrical Systems for use as a diagnostic device.. Recalled by Philips North America Llc. Units affected: 150 US; 192 ROW.
Why was this product recalled? ▼
Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is unable to contain the pressured helium gas due to an unforeseen blockage in the system, risks to patients and/or operators that may lead to injury or death include chemical exposure (i.e. helium gas) that may expand to surrounding rooms, contusion caused by debris, and asphyxia.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 20, 2023. Severity: Critical. Recall number: Z-0505-2024.
Where was the recalled product distributed? ▼
Distribution: Domestic distribution to AL AZ CA CO DE FL GA IA IL IN KS KY LA MA MD MI MO NE NJ NV NY OH OK OR PA SC TN TX UT VA VT WA WI WV International distribution to Argentina Austria Canada China Colombia Croatia Czech Republic Denmark Ecuador Egypt France Germany Greece Italy Kuwait Libya Netherlands NO93 Panama Poland Portugal Qatar Russian Fed. Saint Kitts Saudi Arabia Spain Sweden Switzerland Syria Thailand T¿rkiye United Kingdom Utd.Arab.Emir. Venezuela.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0505-2024) 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 December 20, 2023. 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.