Z-1864-2024Class II
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as...
Philips North America LLC / initiated 2024-05-03 / Open, Classified
Philips North America Llc began a recall of Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified.
Recall record
- Recall number
- Z-1864-2024
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Philips North America LLC
- Product
- Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
- Product code
- LNH System, Nuclear Magnetic Resonance Imaging
- Reason for recall
- 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
- FDA root cause
- Under Investigation by firm
- Action
- 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: [email protected]. 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
- Quantity in commerce
- 4 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Japan, Lebanon, Libya, Lithuania, Martinique, Netherlands, Norway, Poland, Romania, Slovakia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
- Product codes and lots
- UDI-DI: N/A Serial Number: 6102 6115 6101 34007
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1836-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1837-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1838-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1839-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1840-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1841-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1842-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1843-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1844-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1845-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1846-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1847-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1848-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1849-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1850-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1851-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1852-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1853-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1854-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1855-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1856-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1857-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1858-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1859-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1860-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1861-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1862-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1863-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1864-2024 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1865-2024 | Class II | Ongoing | Voluntary: Firm initiated |
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