Recall Z-1326-2013

Hologic, Inc. · initiated April 25, 2013

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging System designed to provide physicians with general fluoroscopic visualization of a patient, including but no limited to surgical orthopedic and podiatry use, critical and emergency procedures, and light anatomy imaging situation.

Codes / lots: Serial numbers per recall strategy.

Reason for recall

The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not accurate.

FDA-determined cause: Software design

Action taken

The firm, Hologic, Inc. sent an "Urgent: Medical Device Recall" letter dated April 25, 2013, via FedEx to consignees/customers notifying them of the software defect and providing them with corrected user installable software version. The customers were instructed to complete and return the Enclosure to Customer Notification, Confirmation of Notification form via fax to Hologic at 866-652-8674 or mail the document to Hologic using the enclosed pre-addressed, pre-paid return envelope. Should you have any questions regarding this recall, require further information or assistance with the software installation call Hologic's Help Desk at 1-800-321-4659.

Details

Recall number
Z-1326-2013
Initiated
April 25, 2013
Posted by FDA
May 17, 2013
Terminated
August 21, 2014
Product code
JAA – System, X-Ray, Fluoroscopic, Image-Intensified
Quantity
287
Distribution
Worldwide distribution: USA (nationwide) and countries of: DE, RU, AU, IT, GB, ES, FR, KR, ZA, CA, AR, LT, TW, CN, BE, AT, JP, QA, SA, SG, HK, SI, NL, and SE.
Recalling firm
Hologic, Inc., Bedford, MA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1327-2013 Class IIFluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a…The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not… 04/25/2013Terminated