MR 5300 recall
Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
Why was MR 5300 recalled?
Potential for alignment errors in the cross reference line functionality when reviewing images generated with the MobiView application.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Numbers: (1) 782110, (2) 782152; UDI-DI: (1) 00884838099364, (2) 00884838112841; Serial Numbers: (1) 63007, 63011, 63022, 63043, 63047, 63050, 63051, 63060, 63074, 63078, 63079, 63082, 63085, 63090, 63095, 63097, 63100, 63116, 63121, 63132, 63136, 63137, 63142, 63143, 63144, 63146, 63150, 63156, 63160, 63162, 63166, 63190, 63202, 63210, 63222, 63226, 63228, 63235, 63238, 63239, 63244, 63247, 63258, 63262, 63263, 63264, 63265, 63266, 63267, 63268, 63269, 63270, 63272, 63274, 63275, 63276, 63281, 63282, 63283, 63284, 63285, 63286, 63287, 63288, 63289, 63290, 63292, 63300, 63303, 63304, 63305, 63306, 63307, 63337, 63352, 63356, 63361, 63363, 63366, 63367, 63370, 63372, 63394, 63456, 63596, 63599, (2) 69000, 69003, 69004, 69005, 69006, 69007, 69008, 69010, 69011, 69012, 69014, 69015, 69016, 69017, 69019, 69020, 69021, 69022, 69023, 69024, 69026, 69027, 69029, 69031, 69032, 69034, 69036, 69037, 69041, 69043, 69044, 69045, 69046, 69048, 69051, 69052, 69053, 69055, 69056, 69058, 69060, 69061, 69063, 69064, 69065, 69066, 69067, 69068, 69069, 69070, 69071, 69072, 69073, 69075, 69076, 69077, 69078, 69080, 69081, 69082, 69085, 69086, 69087, 69089, 69092, 69093, 69094, 69095, 69096, 69097, 69098, 69100, 69102, 69103, 69106, 69107, 69110, 69111, 69112, 69115, 69116, 69121, 69122, 69123, 69124, 69126, 69127, 69130, 69131, 69133, 69136, 69137, 69141, 69147, 69150, 69161, 69170, 69171, 69172, 69176;
- Product
- Product Name: MR 5300; Model Numbers: (1) 782110, (2) 782152;
- Recalling firm
- Philips North America Llc
- Quantity
- 186 units (2 US, 184 OUS)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Andorra, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, C¿te D'Ivoire, Cyprus, Czech Republic, Denmark, Finland, France, French Guiana, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Iceland, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kenya, Latvia, Lebanon, Libya, Lithuania, Malaysia, Malta, Martinique, Mexico, Moldova, Monaco, Netherlands, New Zealand, Norway, Palestine, Philippines, Poland, Portugal, Qatar, Romania, Russian Fed., Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, U.A.E.
- Recall date
- May 28, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)