Hologic, Inc.: 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

Is my product affected?

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.

• UPC 28401082720
• UPC 28407083579

Check against the official notice below — it lists the full affected range.

What happened

Hologic, Inc. is recalling 11 Selenia Full Field Digital Mammography Systems due to a defective relay switch that may prevent the system from turning off when the emergency off switch is activated. This defect could potentially result in patient injury. The affected systems were distributed in California, New York, Texas, Puerto Rico, and the Republic of Korea, and can be identified by specific serial numbers listed in the recall notice.

The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Distribution: Distributed in Puerto Rico, and the states of CA, NY, and TX, and the country of Republic of Korea. Quantity: 11 units Lot/code info: Serial Numbers: 2840314W8065, 2840314W8062W, 2840314W8066W, 2840314W8067 2840314W8073, 2840314W8064, 2840314W8056W, 28401082720 28407083579, 28401137611W, 28403083045W

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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