Philips North America Llc Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346 Recall
Severity assessment pending.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346
Brand
Philips North America Llc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
UDI-DI: 1. (01)00884838068469(21) 2. (01)00884838009806(21) (1) Serial Numbers: 39011 39056 39084 39102 8989 10126 39098 39022 39079 39026 39097 39108 39082 39006 39013 39041 39081 39092 39096 39100 39010 39028 39032 39066 39086 39094 39095 39107 39001 39004 39064 39074 39007 39012 39029 39030 39034 39036 39038 39039 39040 39042 39054 39057 39058 39059 39062 39071 39075 39077 39080 39083 39088 39089 39091 39099 39105 39093 39053 39023 39008 39072 39073 39090 39104 39065 39052 39067 39085 39016 39025 39027 39060 (2) 18052 8361 8415 10015 75008 5243 8727 10172 10189 10545 18737 75002 75003 75004 75015 5547 8059 8767 8842 8883 8886 8897 8946 8981 8990 10060 18001 18710 75009 75092 75095 75099 75100 8276 10194 10512 8069 8312 8520 10006 10048 18588 75000 75001 75005 75049 75087 8289 8367 8714 8740 10539 75011 8351 8398 8782 75068 8756 75010 18505 75007 8371 8124 8467 8020 10219
Philips North America Llc is recalling Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated fo due to The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospit. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fire
Recommended Action
Per FDA guidance
Philips issued Urgent Medical Device Correction notifications to customers on 22-Apr-2024 via FedEx . Philips Markets Organizations are responsible for distributing the letters outside of the US. Letter states reason for recall, health risk and action to take: If a smoke/fire alarm is detected: a. Immediately stop scanning and evacuate the patient and staff from the examination room. b. If a developing fire is detected, adhere to established hospital fire emergency procedures, which may include switching off power to the complete system and/or removing the magnet field by using the Emergency Magnet Off button. c. Do not attempt to continue scanning. d. Immediately contact Philips Service. " Ensure all users are aware of facility specific Emergency Procedures as outlined in Chapter 2: Safety in the Instructions for Use Emergency procedures The User is required to establish emergency procedures for the following situations: " A medical emergency " A fire " An emergency that requires immediate removal of the magnetic field " The release of helium gas into the examination room Philips MRI systems have an Emergency Table Stop button in case there is an emergency during tabletop movement. " Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. " Post this notice near the affected MR system(s) for ease of reference. Please complete and return the attached response form to Philips promptly and no later than 30 days from receipt via email to: pd.cnr@philips.com. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 5. The actions planned by Philips to correct the problem Philips will contact you to schedule time for a Field Service Engineer (FSE) to visit your site to inspect the g-MDU connections in the technical room and apply the proper torque to the connection if necessary.(reference FCO78100582). Philips plans t
Verify this information on the official source
This page aggregates publicly available data. Always confirm recall details directly with the U.S. Food and Drug Administration (FDA) before taking action.
View official FDA recall noticePage updated: Jan 10, 2026
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