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Selenia Dimensions Mammography System, Model number… recallZ-1343-2020 · Hologic, Inc. · initiated Jan 21, 2020

Class II Terminated All recalls posted in February 2020

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Hologic, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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]

Recall details

Recall number
Z-1343-2020
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 21, 2020
Posted by the FDA
Feb 18, 2020
Recalling firm
Hologic, Inc.
Quantity
72
Product code
MUE
FDA submissions
P080003, P010025S013
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 description

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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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

Other devices under the same FDA submission

15 devices cleared under P080003, P010025S013 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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