—#204366

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.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K041602, K052078, K063559
Affected lot / code info: All serial numbers

Why it was recalled

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.

Root cause (FDA determination)

Component design/selection

Action the firm took

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).

Recalling firm

Firm: Philips North America Llc
Address: 222 Jacobs St, Cambridge, Massachusetts 02141-2289

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2023-11-17
Posted by FDA: 2023-12-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204366. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.