Primo AP32211US0010Recalls & reported problems
Arjohuntleigh AB · Bath System - Primo Sys23 HM P220 Disp Des · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05055982716475), received between Mar 9, 2023 and Mar 9, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Tipped Over” (1 report).
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.
Most reported problems
Device problems
- Device Tipped Over1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2023Device Tipped Over; Device Tipped Over
ARJO WAS NOTIFIED OF AN INCIDENT INVOLVING A SYSTEM 2000 BATH. IT WAS INDICATED THAT THE SYSTEM 2000 BATH WAS LOWERED TO ITS LOWEST POINT. THE TUB WAS HALF-FILLED WITH WATER. A PATIENT ENTERED THE TUB AND SAT IN THE BASON WITHOUT THE USE OF ANY SUPPORT EQUIPMENT. THE BATHTUB THEN SHIFTED, AT WHICH POINT THE CAREGIVER HEARD A LOUD BUMP. THE BATHTUB TOUCHED THE FLOOR, AND A CRACK APPEARED ON TOP OF THE BATHTUB. NO INJURIES WERE INDICATED. A MAINTENANCE WORKER FROM THE FACILITY REMOVED THE BACK COVER FROM THE BATHTUB AND FOUND THAT THE SCREW ON THE SIDE CORRESPONDING TO THE CRACK WAS LOOSE. THE MAINTENANCE WORKER TIGHTENED THE SCREW, ESTIMATING THAT THE SCREW WAS STICKING OUT ABOUT HALF AN INCH AND WAS NOT TIGHTENED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16511580 ↗
Other Bath, hydro-massage devices
- Primo AP31212US1011Arjohuntleigh AB · Bath, hydro-massage2 reports
- Century AK61611-USArjohuntleigh AB · Bath, hydro-massage1 report
- Apollo Corp. WP6300Apollo Corp. · Bath, Hydro-Massage1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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