Data Foundry

Medical device recalls 2023

Panorama 1 — Class I medical device recall Z-0505-2024

Ongoing recall by Philips North America Llc, reported 2023-12-20, distributed in AL, AZ, CA, CO, DE, FL, GA, IA…. Firm was informed of an event in which the structural integrity of the MR system components failed due to unin

Recall numberZ-0505-2024
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmPhilips North America Llc, Cambridge, MA, United States
Recall initiated2023-11-17
Classified2023-12-14
Reported by FDA2023-12-20
DistributedAL, 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
Countries outside the USAR, AT, CA, CH, CN, CO, CZ, DE, DK, EC, EG, ES, FR, GB, GR, HR, IT, KW, NL, PA, PL, PT, QA, SA, SE, TH, VE
Reason classeschemical contamination
Model numbers781250, 781350

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0505-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.