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RecallWatchMedical Device Safety
Class IIOngoingZ-2219-2025

FUJIFILM Healthcare Americas Corporation recalls ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE…

FUJIFILM Healthcare Americas CorporationLexington, MA, United StatesReported Aug 6, 2025 · 11 months ago
Legal News Analyst ·

Reason for recall

Devices had an unapproved slabbing software function enabled for use.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

Lot / code information

Model
CLLE-0229
UDI
(01)01547410297546(11)210701(21)16724035, (01)045474100297546(11)191001(21)967022860, (01)045474100297546(11)191001(21)97022857, (01)045474100297546(11)191001(21)97022858, (01)045474100297546(11)191001(21)97022861, (01)04547410294546(11)190801(21)96822763 — +205 moreShow all
(01)01547410297546(11)210701(21)16724035, (01)045474100297546(11)191001(21)967022860, (01)045474100297546(11)191001(21)97022857, (01)045474100297546(11)191001(21)97022858, (01)045474100297546(11)191001(21)97022861, (01)04547410294546(11)190801(21)96822763, (01)04547410294546(11)190801(21)96822764, (01)04547410294546(11)190801(21)96822765, (01)04547410294546(11)190801(21)96822767, (01)04547410294576(11)210501(21)16523949, (01)04547410294576(11)210501(21)16523950, (01)04547410294576(11)210601(21)16623962, (01)04547410294576(11)210601(21)16623963, (01)04547410297546(01)170601(21)76621287, (01)04547410297546(11)000100(21)67121008, (01)04547410297546(11)160107(21)66120675, (01)04547410297546(11)170201(21)76221098, (01)04547410297546(11)170220(21)67121004, (01)04547410297546(11)170301(21)76321131, (01)04547410297546(11)170301(21)76321132, (01)04547410297546(11)170301(21)76321136, (01)04547410297546(11)170501(21)76521235, (01)04547410297546(11)170501(21)76521236, (01)04547410297546(11)170501(21)76521237, (01)04547410297546(11)170501(21)76521238, (01)04547410297546(11)170720(21)76621277, (01)04547410297546(11)170731(21)76621278, (01)04547410297546(11)170801(21)76821374, (01)04547410297546(11)170801(21)76821375, (01)04547410297546(11)170923(21)76121056, (01)04547410297546(11)171001(21)77021484, (01)04547410297546(11)171001(21)77021485, (01)04547410297546(11)171001(21)77021486, (01)04547410297546(11)171006(21)76821376, (01)04547410297546(11)171101(77)121559, (01)04547410297546(11)171101(77)121560, (01)04547410297546(11)171101(77)121561, (01)04547410297546(11)180101(01)86121657, (01)04547410297546(11)180101(86)121658, (01)04547410297546(11)180101(86)121659, (01)04547410297546(11)180101(86)121660, (01)04547410297546(11)180423(21)76421207, (01)04547410297546(11)180502(21)86321784, (01)04547410297546(11)180518(21)76421208, (01)04547410297546(11)181026(21)86421848, (01)04547410297546(11)190103(21)77221602, (01)04547410297546(11)190109(21)77221600, (01)04547410297546(11)190215(21)86221736, (01)04547410297546(11)190426(21)86421849, (01)04547410297546(11)190523(21)86221735, (01)04547410297546(11)190605(21)86622007, (01)04547410297546(11)190607(21)67121009, (01)04547410297546(11)190614(21)87022245, (01)04547410297546(11)190716(21)86622008, (01)04547410297546(11)190801(21)96822766, (01)04547410297546(11)190801(21)96822768, (01)04547410297546(11)190801(21)96822769, (01)04547410297546(11)190802(21)96522600, (01)04547410297546(11)190805(21)96422570, (01)04547410297546(11)190816(21)67121002, (01)04547410297546(11)190823(21)96522602, (01)04547410297546(11)190901(21)96622828, (01)04547410297546(11)190901(21)96922826, (01)04547410297546(11)190901(21)96922827, (01)04547410297546(11)190901(21)96922829, (01)04547410297546(11)190901(21)96922830, (01)04547410297546(11)190901(21)96922834, (01)04547410297546(11)191001(21)97022856, (01)04547410297546(11)191001(21)97022859, (01)04547410297546(11)191004(21)96622652, (01)04547410297546(11)191004(21)96622653, (01)04547410297546(11)191029(21)67121006, (01)04547410297546(11)191101(21)97122920, (01)04547410297546(11)191101(21)97122921, (01)04547410297546(11)191101(21)97122922, (01)04547410297546(11)191101(21)97122923, (01)04547410297546(11)191101(21)97122924, (01)04547410297546(11)191101(21)97122925, (01)04547410297546(11)191101(21)97122926, (01)04547410297546(11)191101(21)97122927, (01)04547410297546(11)191101(21)97122929, (01)04547410297546(11)191101(21)97122930, (01)04547410297546(11)191101(21)97122931, (01)04547410297546(11)191101(21)97122932, (01)04547410297546(11)191201(21)97222975, (01)04547410297546(11)191201(21)97222976, (01)04547410297546(11)191201(21)97222977, (01)04547410297546(11)191201(21)97222978, (01)04547410297546(11)191201(21)97222979, (01)04547410297546(11)191201(21)97222980, (01)04547410297546(11)191201(21)97222981, (01)04547410297546(11)191201(21)97222982, (01)04547410297546(11)191201(21)97222983, (01)04547410297546(11)191201(21)97222984, (01)04547410297546(11)191201(21)97222985, (01)04547410297546(11)191201(21)97222986, (01)04547410297546(11)191201(21)97222987, (01)04547410297546(11)191201(21)97222988, (01)04547410297546(11)191206(21)96522599, (01)04547410297546(11)191216(21)87022244, (01)04547410297546(11)200101(21)06123029, (01)04547410297546(11)200101(21)06123031, (01)04547410297546(11)200101(21)06123034, (01)04547410297546(11)200101(21)06123035, (01)04547410297546(11)200101(21)06123036, (01)04547410297546(11)200101(21)06123037, (01)04547410297546(11)200101(21)06123038, (01)04547410297546(11)200101(21)06123039, (01)04547410297546(11)200101(21)06123040, (01)04547410297546(11)200201(21)06223076, (01)04547410297546(11)200201(21)06223077, (01)04547410297546(11)200201(21)06223078, (01)04547410297546(11)200201(21)06223079, (01)04547410297546(11)200201(21)06223080, (01)04547410297546(11)200201(21)06223081, (01)04547410297546(11)200201(21)06223082, (01)04547410297546(11)200201(21)06223083, (01)04547410297546(11)200201(21)06223084, (01)04547410297546(11)200201(21)06223085, (01)04547410297546(11)200201(21)06223086, (01)04547410297546(11)200201(21)06223087, (01)04547410297546(11)200301(21)06323188, (01)04547410297546(11)200301(21)06323189, (01)04547410297546(11)200401(21)06423194, (01)04547410297546(11)200401(21)06423195, (01)04547410297546(11)200401(21)06423196, (01)04547410297546(11)200401(21)06423197, (01)04547410297546(11)200401(21)06423198, (01)04547410297546(11)200401(21)06423199, (01)04547410297546(11)200401(21)06423200, (01)04547410297546(11)200401(21)06423201, (01)04547410297546(11)200501(21)06423202, (01)04547410297546(11)200501(21)06523263, (01)04547410297546(11)200501(21)06523264, (01)04547410297546(11)200501(21)06523265, (01)04547410297546(11)200501(21)06523266, (01)04547410297546(11)200501(21)06523268, (01)04547410297546(11)200501(21)06523269, (01)04547410297546(11)200501(21)06523270, (01)04547410297546(11)200601(21)06623347, (01)04547410297546(11)200601(21)06623348, (01)04547410297546(11)200601(21)06623350, (01)04547410297546(11)200601(21)06623351, ( …
Serial #
16223805, 16323842, 16323843, 16323844, 16323845, 16523949 — +286 moreShow all
16223805, 16323842, 16323843, 16323844, 16323845, 16523949, 16523950, 16623962, 16623963, 16623964, 16623965, 16623966, 16623967, 16623968, 16623969, 16623970, 16623971, 16623972, 16623973, 16623974, 16623975, 16623975, 16623977, 16623977, 16623978, 16623978, 16623979, 16623980, 16623981, 16623981, 16623982, 16623982, 16724026, 16724027, 16724028, 16724031, 16724032, 16724033, 16724034, 16724035, 16824048, 16824049, 16824050, 16824051, 16824052, 16824054, 16824055, 16824056, 16824057, 16924082, 16924083, 17224248, 17224249, 26124301, 26224330, 26224331, 36725231, 36725231, 36725234, 36725239, 36725244, 36725250, 36825283, 36825284, 36825287, 36825288, 36825291, 36925334, 36925335, 36925343, 37025388, 37025389, 37125425, 37125426, 37125430, 46220029, 56920525, 57020577, 6123029, 6123031, 6123032, 6123033, 6123034, 6123035, 6123036, 6123037, 6123038, 6123039, 6123040, 6223076, 6223077, 6223078, 6223079, 6223080, 6223081, 6223082, 6223083, 6223084, 6223085, 6223086, 6223087, 6323188, 6323189, 6423194, 6423195, 6423196, 6423197, 6423198, 6423199, 6423200, 6423201, 6423202, 6523263, 6523264, 6523265, 6523266, 6523268, 6523269, 6523270, 66120669, 66120675, 66120676, 6623347, 6623348, 6623349, 6623350, 6623351, 6623352, 6623353, 66820905, 67121002, 67121004, 67121006, 67121008, 67121009, 76121055, 76121056, 76221098, 76221100, 76221108, 76321131, 76321132, 76321136, 76421207, 76421208, 76521235, 76521236, 76521237, 76521238, 76621277, 76621278, 76621287, 76721324, 76721325, 76821374, 76821375, 76821376, 77021484, 77021485, 77021486, 77121559, 77121560, 77121561, 77221600, 77221601, 77221602, 86121657, 86121658, 86121659, 86121660, 86221735, 86221736, 86221737, 86321784, 86421848, 86421849, 86421850, 86421851, 86521911, 86622007, 86622008, 87022243, 87022244, 87022245, 96422570, 96522599, 96522600, 96522601, 96522602, 96522603, 96622652, 96622653, 96622654, 96622655, 96722706, 96722707, 96822763, 96822764, 96822765, 96822766, 96822767, 96822768, 96822769, 96922826, 96922827, 96922828, 96922829, 96922830, 96922834, 97022856, 97022857, 97022858, 97022859, 97022860, 97022861, 97122920, 97122921, 97122922, 97122923, 97122924, 97122925, 97122926, 97122927, 97122928, 97122929, 97122930, 97122931, 97122932, 97222975, 97222976, 97222977, 97222978, 97222979, 97222980, 97222981, 97222982, 97222983, 97222984, 97222985, 97222986, 97222987, 97222988, 9922655, CLLE-0181, CLLE-0182, CLLE-0183, CLLE-0184, CLLE-0185, CLLE-0186, CLLE-0187, CLLE-0188, CLLE-0189, CLLE-0190, CLLE-0191, CLLE-0192, CLLE-0193, CLLE-0194, CLLE-0195, CLLE-0196, CLLE-0197, CLLE-0198, CLLE-0199, CLLE-0200, CLLE-0201, CLLE-0202, CLLE-0203, CLLE-0204, CLLE-0205, CLLE-0206, CLLE-0207, CLLE-0208, CLLE-0209, CLLE-0210, CLLE-0211, CLLE-0212, CLLE-0213, CLLE-0214, CLLE-0215, CLLE-0216, CLLE-0217, CLLE-0218, CLLE-0219, CLLE-0220, CLLE-0221, CLLE-0222, CLLE-0223, CLLE-0224, CLLE-0225, CLLE-0226, CLLE-0227, CLLE-0228, CLLE-0229

What the firm is doing

An URGENT: MEDICAL DEVICE RECALL FIRST NOTICE, dated 6/10/25, was sent to consignees. Consignees are to post the notification on/near affected devices and return the completed response form to coordinate a field service engineer to visit. Fujifilm will be sending a Fujifilm healthcare engineer to inspect affected systems and correct the settings to ensure the slabbing feature is inactive. Customers with any questions can contact Fujifilm Customer Service at 1-888-385-4633 or Fujifilm's Field Action Coordinator, Jay Wigley, at hcusquality@fujifilm.com. Functional/upgrade questions can be directed to the Technical Assistance Center at 1-888-385-4622.

DistributionShow details

Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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