SENSE Breast Coil
This recall is currently active, issued November 25, 2024. It was issued by Philips North America Llc.
- Company
- Philips North America Llc
- Recall Initiated
- November 4, 2024
- Posted
- November 25, 2024
- Recall Number
- Z-0545-2025
- Quantity
- 5,231 units
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Potential safety issue where a patient may be harmed while preparing for or during a scan.
Distribution
US Nationwide distribution.
Lot / Code Info
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.
Root Cause
Use error
Action Taken
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.