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

Recall number

Z-2219-2025

Recalling firm

FUJIFILM Healthcare Americas Corporation

Product

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

Status

Open, Classified

Initiated

2025-06-11

Posted

2025-07-30

Terminated

not on file

Reason

Devices had an unapproved slabbing software function enabled for use.

Root cause

Process control

Action

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.

Quantity

293 units

Distribution

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

Lot, serial or model codes

Model No. 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, (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, 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(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, 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(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, 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(01)04547410297546(11)231215(21)36825291, (01)04547410297546(11)231221(21)36725234, (01)04547410297546(11)240126(21)36725250, (01)04547410297546(11)240126(21)36925343, (01)04547410297546(11)240130(21)36925334, (01)04547410297546(11)240220(21)37025389, (01)04547410297546(11)240223(21)16623978, (01)04547410297546(11)240301(21)36925335, (01)04547410297546(11)240308(21)37025388, (01)04547410297546(11)240322(21)16623981, (01)04547410297546(11)240326(21)36725231, (01)04547410297546(11)240329(21)16623980, (01)04547410297546(11)240418(21)16824054, (01)04547410297546(11)240501(21)37125430, (01)04547410297546(11)240509(21)16623979, (01)04547410297546(11)240523(21)96622655, (01)04547410297546(11)240606(21)16824057, (01)04547410297546(11)240620(21)16623982, (01)04547410297546(11)240712(21)37125426, (01)04547410297546(11)240815(21)37125425, (01)04547410297546(11)240816(21)46525681, (01)04547410297546(11)240923(21)36825287, (01)04547410297546(11)240926(21)16623975, (01)04547410297546(11)241213(21)16323845, (01)04574102975456(11)17070176721324, (01)04574102975456(11)17070176721325; Serial No. 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, 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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.

510(k) numbers

not on file

PMA numbers

["P160031"]

Product code

OTE

Firm FEI

1000513161

Firm city

Lexington

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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