The Recall Desk

FDA (Devices) recall action 76905

Fujifilm Medical Systems U.S.A., Inc. recalled 2 products on 2017-09-20

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2017-09-20
Critical
0
Units
520

Why these products were recalled

Fujifilm is conducting a corrective action due to an FDA inspection.

Fujifilm is reporting a corrective action due to an FDA inspection.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Devices)··2017-09-20

    Fujifilm Endoscope Corrective Action Following FDA Inspection

    Fujifilm Medical Systems U.S.A., Inc. is conducting a corrective action for specific endoscope models following an FDA inspection.

    Product
    Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2017-09-20

    Fujifilm ED-530XT Endoscope Manuals Recalled Following FDA Inspection

    Fujifilm is recalling 260 user manuals for the ED-530XT endoscope following an FDA inspection. The recall is a corrective action to address documentation issues.

    Product
    Fujifilm Endoscope Model ED-530XT Product Usage: This product is a medical endoscope for the duodenum and upper GI tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other pur
    Category
    Distribution
    0 states