| | Class 2 Device Recall ASPIRE Cristalle Mammography System |  |
| Date Initiated by Firm | June 11, 2025 |
|---|
| Date Posted | July 30, 2025 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2219-2025 |
|---|
| Recall Event ID |
97063 |
| PMA Number | P160031 |
|---|
| Product Classification |
Digital breast tomosynthesis - Product Code OTE
|
| Product | ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031). |
|---|
| Code Information |
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, (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, (01)04547410297546(11)200601(21)06623352, (01)04547410297546(11)200601(21)06623353, (01)04547410297546(11)200910(21)86221737, (01)04547410297546(11)201218(21)97122928, (01)04547410297546(11)210201(21)16223805, (01)04547410297546(11)210226(21)86521911, (01)04547410297546(11)210301(21)16323843, (01)04547410297546(11)210301(21)16323844, (01)04547410297546(11)210323(21)96522601, (01)04547410297546(11)210519(21)87022243, (01)04547410297546(11)210601(21)16623964, (01)04547410297546(11)210601(21)16623965, (01)04547410297546(11)210601(21)16623966, (01)04547410297546(11)210601(21)16623967, (01)04547410297546(11)210601(21)16623968, (01)04547410297546(11)210701(21)16724027, (01)04547410297546(11)210701(21)16724028, (01)04547410297546(11)210701(21)16724031, (01)04547410297546(11)210701(21)16724032, (01)04547410297546(11)210701(21)16724033, (01)04547410297546(11)210701(21)16724034, (01)04547410297546(11)210801(21)16824048, (01)04547410297546(11)210801(21)16824049, (01)04547410297546(11)210801(21)16824050, (01)04547410297546(11)210801(21)16824051, (01)04547410297546(11)210801(21)16824052, (01)04547410297546(11)210801(21)16824055, (01)04547410297546(11)210801(21)16824056, (01)04547410297546(11)211001(21)6623349, (01)04547410297546(11)220124(21)96722707, (01)04547410297546(11)220314(21)6123033, (01)04547410297546(11)220411(21)77221601, (01)04547410297546(11)220915(21)16323843, (01)04547410297546(11)230818(21)96522603, (01)04547410297546(11)230915(21)6123032, (01)04547410297546(11)231026(21)96722706, (01)04547410297546(11)231102(21)66120676, (01)04547410297546(11)231110(21)36725244, (01)04547410297546(11)231116(21)16623977, (01)04547410297546(11)231130(21)36825284, (01)04547410297546(11)231130(21)36825288, (01)04547410297546(11)231214(21)36825283, (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, 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. |
| FEI Number |
1000513161
|
Recalling Firm/
Manufacturer |
FUJIFILM Healthcare Americas Corporation
81 Hartwell Ave Ste 300
Lexington MA 02421-3160
|
| For Additional Information Contact | Kotei Aoki
765-246-2931 |
|---|
Manufacturer Reason
for Recall | Devices had an unapproved slabbing software function enabled for use. |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 293 units |
|---|
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| PMA Database | PMAs with Product Code = OTE
|
|---|
|
|
|
