Recall Z-0505-2024— Philips North America Llc

Name: FDA recall Z-0505-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-17

Class I · Ongoing

Class I FDA medical device recall by Philips North America Llc, initiated 2023-11-17. It names 3 FDA 510(k) clearances: K063559, K052078, K041602. 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..

Recalling firm: Philips North America Llc
Classification: Class I
Status: Ongoing
Initiated: 2023-11-17
Firm location: Cambridge, MA, United States

510(k) clearances named in this recall

3 on FDA's record

K063559 — ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5Philips Medical Systems·cleared 2007-01-04
K052078 — ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIESPhilips Medical Systems Nederland B.V.·cleared 2005-09-07
K041602 — PANORAMA 1.0TPhilips Medical Systems North America, Inc.·cleared 2004-07-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.