FDA Device recall Z-0505-2024
Panorama 1.0T HFO, Magnetic Resonance (MR) System
- FDA Device
- Class I
- ongoing
- Published 2023-12-20
On 2023-12-20 the FDA classified a Class I recall of Panorama 1.0T HFO, Magnetic Resonance (MR) System by Philips North America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0505-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-17 |
| Published | 2023-12-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Philips North America |
| Distribution | 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 |
Product
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
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.
Identifiers
| code_info | All serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0505-2024%22
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