Panorama 1.0T HFO, Magnetic Resonance (MR) System; Model Numbers 781250 and 781350. Philips Magnetic Resonance (MR) syst

FDA device recall Z-0505-2024 · posted 2023-12-14 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

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.

Action taken

On November 17, 2023, the firm issued an URGENT Medical Device Correction letter to affected consignees. Customers were provided instructions on how to identify impacted systems. Customers with impacted systems should immediately discontinue use of their impacted MR system. Philips is requesting that customers immediately stop using the MR systems until an inspection can be completed. Philips will contact customers to schedule an on-site visit by a Field Service Engineer to inspect your system starting in December 2023. If you need any further information or support concerning this issue, please contact your local Philips representative: For North America, contact the Customer Care Solutions Center (1-800-722-9377).

Root cause

Component design/selection

Status

Open, Classified

Product code

LNH

Quantity affected

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 Cro

Date initiated

2023-11-17

Date posted

2023-12-14

Location

Cambridge, MA

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