Recall Z-1700-2014— Hologic, Inc.
Class II · Terminated
Class II FDA medical device recall by Hologic, Inc., initiated 2014-05-13, terminated 2014-08-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.. Reason: Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury.
- Recalling firm
- Hologic, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-13
- Terminated
- 2014-08-18
- Firm location
- Danbury, CT, United States
Product description
Hologic Selenia Full Field Digital Mammography System: SEL-00002, SEL-00013, SEL-00030, SEL-00039. The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer.
Reason for recall
Selenia Full Field Digital Mammography System defective relay switch, if there is a need to use the emergency off switch, the system may not turn off which could result in patient injury
Data sourced from openFDA. This site is unofficial and independent of the FDA.