Z-1343-2020Class II

Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636

Name: Z-1343-2020 Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636
Creator: Hologic, Inc.
Published: 2020-01-21
License: https://open.fda.gov/license/

Hologic, Inc. / initiated 2020-01-21 / Terminated / root cause: manufacturing process

FDA source

Hologic, Inc. began a recall of Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636 on 2020-01-21. FDA classified it as Class II and gives the reason as "The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1343-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-21
Posted: 2020-02-18
Terminated: 2021-08-11
Recalling firm: Hologic, Inc.
Product: Selenia Dimensions Mammography System, Model number ASY-04160, Selenia Dimensions Gantry, UDI 15420045505636,
Product code: MUE Full Field Digital, System, X-Ray, Mammographic
Reason for recall: The recalling firm has received reports from the field of the C-arm on the Selenia Dimensions system seizing or dropping during field repairs and cleaning of the systems.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On January 21, 2020, the firm notified affected customers of the recall via hand-delivered Urgent Medical Device Correction letter. Customers were informed that the firm had received reports of the C-arm seizing or dropping during field repairs and cleaning of the systems. In order to ensure continued safe use of the system, Hologic sent field service engineers to customer sites on January 21, 2020, to inspect affected systems. Customers were asked to not use the system until the inspection was completed. If you have any questions, please contact Technical Support at [email protected]
Quantity in commerce: 72
Distribution: Domestic distribution to 14 states: AK AZ CA CO CT DC FL GA IA ID IL MA MO NC NH NJ NY OH SD TX VA. Foreign distribution to Italy, United Kingdom, Saudi Arabia, Brazil, Costa Rica, Spain, Canada, Cyprus, Germany, France, Korea, Kuwait, The Netherlands, Oman, Peru, and Russia.
Product codes and lots: Serial Numbers 81002143175 81002143176 81002143177 81003143178 81003143179 81003143180 81003143181 81003143182 81003143183 81003143184 81003143185 81003143186 81003143187 81003143188 81003143189 81003143190 81003143191 81003143192 81003143193 81003143194 81003143195 81003143196 81003143197 81003143198 81003143199 81003143200 81003143201 81003143202 81003143203 81003143204 81003143205 81003143206 81003143207 81003143208 81003143209 81003143210 81003143211 81003143212 81003143213 81003143214 81003143215 81003143216 81003143217 81003143218 81003143219 81003143220 81003143221A 81003143222A 81003143223 81003143224A 81003143225 81003143226 81003143227 81003143228 81003143229 81003143230 81003143231 81003143232 81003143234 81003143235 81003143236 81003143237 81003143238 81003143239 81003143240 81003143241 81003143242 81003143243 81003143244 81003143245 81003143246A 81003143247

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1343-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1343-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-21

Product code MUE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)