SENSE Breast Coil (Philips) – patient safety issue (2024)
Hazard assessment based on recall description.
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
SENSE Breast Coil
Brand
Philips North America Llc
Lot Codes / Batch Numbers
REF: 453530083951, UDI-DI: 00884838066588, Serial No. 36987, 36587, 36690, 36898, 37009, 36637, 37129, 37140, 36957, 36549, 36548, 36547, 36893, 36678, 36736, 36743, 36744, 36763, 36770, 36882, 36897, 36938, 36939, 37012, 36585, 36622, 36618, 36639, 36635, 36650, 36648, 36732, 36681, 36676, 36769, 36861, 36885, 36878, 36883, 36890, 36894, 36950, 36941, 36994, 37000, 36998, 36993, 37130, 37159, 37160, 36874, 37032, 37053, 37208, 37127, 37148, 37151, 37143, 36559, 37007, 37141, 36544, 36552, 36580, 36557, 36564, 36630, 36738, 36754, 36762, 36768, 36592, 36603, 36632, 36629, 36673, 36626, 36667, 36660, 36671, 36653, 36691, 36737, 36740, 36749, 36735, 36750, 36747, 36771, 36796, 36803, 36798, 36802, 36794, 36812, 36842, 36741, 36847, 36930, 36865, 36860, 36864, 36867, 36877, 36853, 36884, 36876, 36919, 36880, 36896, 36901, 36891, 36963, 36933, 36899, 36908, 36913, 36907, 36912, 36915, 36983, 36972, 36929, 36931, 36935, 36928, 36927, 36943, 36932, 36942, 36992, 36945, 36940, 36948, 36955, 36949, 37003, 36954, 36953, 36956, 36967, 36966, 36962, 36989, 37004, 37006, 37022, 36974, 37043, 37015, 37020, 37001, 37005, 37014, 37018, 37038, 37072, 37010, 37011, 37026, 37024, 37017, 37019, 37021, 37028, 36988, 37025, 37051, 37055, 37084, 37031, 37029, 37070, 37036, 37042, 37052, 37071, 37056, 37034, 37074, 37092, 37041, 37080, 37079, 37095, 37090, 37118, 37133, 37125, 37085, 37124, 37142, 37122, 37150, 37163, 37139, 37147, 37137, 37176, 37173, 37157, 37155, 37152, 37161, 37179, 37164, 37162, 37191, 37181, 37182, 37188, 37243, 37226, 37190, 37192, 37206, 37195, 37207, 37238, 37214, 37222, 37225, 37234, 37264, 36662, 37280, 36581, 36910, 37040, 37016, 37128, 37138, 37165, 36873, 36996, 36606, 36920, 37169, 37268, 37265, 36553, 36652, 36797, 36905, 37282, 37283, 36947, 37167, 36633, 36624, 37136, 36565, 36636, 36644, 36661, 36654, 36602, 36730, 36758, 36815, 36839, 36862, 36888, 36895, 36926, 36997, 36991, 36985, 37008, 37078, 37126, 37154, 37178, 37174, 37184, 37193, 37186, 37199, 37185, 37189, 37175, 37273, 37242, 37272, 37267, 37224, 37119, 37131, 37123, 37153, 37166, 37200, 37210, 37196, 37223, 37211, 37239, 37266, 36655, 37044, 37039, 36801, 36809, 36537, 36576, 36556, 36568, 36535, 36666, 36674, 37281, 37083, 37076, 37114, 36863, 36811, 37097, 36871, 36575, 36599, 36638, 36600, 36649, 37054, 36566, 36806, 36808, 37096, 36545, 36623, 37121, 36795, 36608, 36611, 36964, 36973, 36669, 36586, 36583, 36904, 36569, 36960, 36921, 36923, 36936, 36951, 37035, 36946, 37177, 37221, 36846, 36625, 36677, 36817, 36870, 36748, 36563, 36539, 36698, 36664, 36686, 36810, 36914, 37183, 36577, 37073, 36656, 36813, 36909, 36906.
Products Sold
REF: 453530083951; UDI-DI: 00884838066588; Serial No. 36987, 36587, 36690, 36898, 37009, 36637, 37129, 37140, 36957, 36549, 36548, 36547, 36893, 36678, 36736, 36743, 36744, 36763, 36770, 36882, 36897, 36938, 36939, 37012, 36585, 36622, 36618, 36639, 36635, 36650, 36648, 36732, 36681, 36676, 36769, 36861, 36885, 36878, 36883, 36890, 36894, 36950, 36941, 36994, 37000, 36998, 36993, 37130, 37159, 37160, 36874, 37032, 37053, 37208, 37127, 37148, 37151, 37143, 36559, 37007, 37141, 36544, 36552, 36580, 36557, 36564, 36630, 36738, 36754, 36762, 36768, 36592, 36603, 36632, 36629, 36673, 36626, 36667, 36660, 36671, 36653, 36691, 36737, 36740, 36749, 36735, 36750, 36747, 36771, 36796, 36803, 36798, 36802, 36794, 36812, 36842, 36741, 36847, 36930, 36865, 36860, 36864, 36867, 36877, 36853, 36884, 36876, 36919, 36880, 36896, 36901, 36891, 36963, 36933, 36899, 36908, 36913, 36907, 36912, 36915, 36983, 36972, 36929, 36931, 36935, 36928, 36927, 36943, 36932, 36942, 36992, 36945, 36940, 36948, 36955, 36949, 37003, 36954, 36953, 36956, 36967, 36966, 36962, 36989, 37004, 37006, 37022, 36974, 37043, 37015, 37020, 37001, 37005, 37014, 37018, 37038, 37072, 37010, 37011, 37026, 37024, 37017, 37019, 37021, 37028, 36988, 37025, 37051, 37055, 37084, 37031, 37029, 37070, 37036, 37042, 37052, 37071, 37056, 37034, 37074, 37092, 37041, 37080, 37079, 37095, 37090, 37118, 37133, 37125, 37085, 37124, 37142, 37122, 37150, 37163, 37139, 37147, 37137, 37176, 37173, 37157, 37155, 37152, 37161, 37179, 37164, 37162, 37191, 37181, 37182, 37188, 37243, 37226, 37190, 37192, 37206, 37195, 37207, 37238, 37214, 37222, 37225, 37234, 37264, 36662, 37280, 36581, 36910, 37040, 37016, 37128, 37138, 37165, 36873, 36996, 36606, 36920, 37169, 37268, 37265, 36553, 36652, 36797, 36905, 37282, 37283, 36947, 37167, 36633, 36624, 37136, 36565, 36636, 36644, 36661, 36654, 36602, 36730, 36758, 36815, 36839, 36862, 36888, 36895, 36926, 36997, 36991, 36985, 37008, 37078, 37126, 37154, 37178, 37174, 37184, 37193, 37186, 37199, 37185, 37189, 37175, 37273, 37242, 37272, 37267, 37224, 37119, 37131, 37123, 37153, 37166, 37200, 37210, 37196, 37223, 37211, 37239, 37266, 36655, 37044, 37039, 36801, 36809, 36537, 36576, 36556, 36568, 36535, 36666, 36674, 37281, 37083, 37076, 37114, 36863, 36811, 37097, 36871, 36575, 36599, 36638, 36600, 36649, 37054, 36566, 36806, 36808, 37096, 36545, 36623, 37121, 36795, 36608, 36611, 36964, 36973, 36669, 36586, 36583, 36904, 36569, 36960, 36921, 36923, 36936, 36951, 37035, 36946, 37177, 37221, 36846, 36625, 36677, 36817, 36870, 36748, 36563, 36539, 36698, 36664, 36686, 36810, 36914, 37183, 36577, 37073, 36656, 36813, 36909, 36906.
Philips North America Llc is recalling SENSE Breast Coil due to Potential safety issue where a patient may be harmed while preparing for or during a scan.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Recommended Action
Per FDA guidance
An URGENT MEDICAL DEVICE CORRECTION notice dated 10/31/24 was mailed to consignees. Consignees are to continue using affected systems in accordance with the intended use. When using the system follow section PRECAUTIONS, CAUTIONS & WARNINGS in the Instructions For Use (IFU). Consignees are to circulate the recall notice to all users for their awareness of the potential issue. The Recall Response Form is to be provided back to Philips MR within 30 days at Philips.Recall@philips.com. Customers with any questions are to contact their local Philips Representative.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026