Ingenuity Flex 728317Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838059528), received between Aug 13, 2023 and Aug 13, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended System Motion” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 1, 2021Open, Classified

   Significant wear of the Monitor Bracket Assembly shaft goes unrecognized could potentially lead to the Monitor Bracket Assembly detaching from the Suspension Arm and result in potential hazard for the monitor to fall while remaining attached to the cables resulting in patient, operator, bystander, or service person to serious injury.

   Z-1982-2021 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2023Unintended System Motion; No Apparent Adverse Event; Unintended System Motion; No Apparent Adverse Event

  THIS COMPLAINT HAS BEEN EVALUATED BASED ON THE INFORMATION PROVIDED. THE CUSTOMER REPORTED THAT AFTER A PATIENT SCANNING WAS COMPLETED, THE PATIENT COUCH SUDDENLY DROPPED WHILE LOWERING THE COUCH. PHILIPS FIELD SERVICE ENGINEER(FSE) INSPECTED SYSTEM AND IDENTIFIED THAT BALL BEARING AND BALL SCREW WERE DEFECTIVE. FSE HAD THE NEW BALL BEARING SERVICE KIT INSTALLED AND RETURNED THE SYSTEM TO CUSTOMER FOR CLINICAL USE. PATIENT WAS FRIGHTENED BUT WAS NOT ACTUALLY HARMED. A SIMILAR PRODUCT REGARDING COUCH DROPPING DOWNWARDS RAPIDLY WAS RECENTLY ASSESSED AS POTENTIAL FOR SERIOUS INJURY IF IT WERE TO RECUR. BASED ON THAT ASSESSMENT, WE ARE CONSIDERING THIS EVENT REPORTABLE OUT OF ABUNDANCE OF CAUTION. PHILIPS HAS STARTED AN INVESTIGATION OF THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538212 ↗