Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) syst
Summary
The FDA issued a Class I for Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 7813 by Philips North America Llc. 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 hel.
Details
Source
Device Recall
External ID
Z-0505-2024
Action Date
2023-12-20
Status
Ongoing
Category
device
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.
Lot/Code Info: All serial numbers
Quantity Affected: 150 US; 192 ROW
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-17
Company
Cambridge, MA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 238 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Philips North America Llc has 302 FDA actions in our database, including 302 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Philips North America Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Philips North America Llc have FDA actions?
Philips North America Llc has 302 FDA actions in our database, including 302 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0505-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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