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Ingenia recallZ-1862-2024 · Philips North America Llc · initiated May 3, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Philips North America Llc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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 category: Under Investigation by firm

What the company is doing

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

Recall details

Recall number
Z-1862-2024
Status
Open, Classified
Initiated by the company
May 3, 2024
Posted by the FDA
May 17, 2024
Recalling firm
Philips North America Llc
Quantity
200 units
Product code
LNH
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 description

SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI-DI: (1) 782129 (01)00884838105805(21); (2) 782113 (01)00884838098909(21); (3) 781270 (01)00884838095083(21) Serial Numbers: Serial Number 17536 17546 17212 17508 23011 35056 17434 17302 17429 24108 17006 17378 17386 17533 17590 35052 17204 17264 17292 17339 17398 17415 17416 17436 17440 17447 17544 23030 24055 35087 17473 17283 17247 17265 17268 17286 17353 17367 17389 17425 17509 17517 17572 17580 24022 24036 24098 35020 35078 23002 24018 17514 17524 23026 24087 24095 17260 17222 17242 17245 17250 17269 17299 17308 17309 17342 17357 17388 17399 17464 17468 17493 17499 17556 17559 17564 17565 17569 17589 17594 24006 24012 24023 24047 24109 24110 24111 24124 24134 24143 35027 35046 35048 38015 17305 24117 17266 17471 17428 38131 17194 17246 23036 17610 17550 24145 34250 17237 17352 17321 17344 17495 17570 17615 24020 24090 17274 35047 17326 17466 24075 17172 17360 17369 17490 24007 24025 38199 17356 17406 17206 17239 17240 17284 17375 17459 17516 23033 24058 24076 35019 35032 35040 17366 17215 17376 17449 17455 17470 34059 34262 38106 17252 34172 38070 38142 17439 38350 74040 17504 34072 35041 38105 17271 17346 24021 24077 24093 24146 34117 34127 34128 34129 34131 34153 34202 35059 38094 38290 38311 17258 38310 34212 38042 38281 17560 38166 38183 24039 34110 38117 17521 38010 38219 17307 38075 38222 34055 38195

Devices named in this recall

3 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94508).

Sources and updates

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