DORO® Base Unit 3001-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04250435500019), received between Oct 19, 2023 and Jun 20, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Malposition of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2024Malposition of Device; Malposition of Device

  DISTRIBUTOR INFORMED US ON MAY 23 THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A PROCEDURE WHOSE COMPLETION HAD TO BE CANCELLED AND RESCHEDULED DUE TO MISALIGNMENT OF THE SYSTEM. SPECIFICALLY, THE PRODUCT WAS REPORTEDLY USED FOR THE FIRST TIME IN A PROCEDURE ON APRIL 20. DURING THE PROCEDURE, THE RESPONSIBLE SURGEON NOTICED THAT THE CLAMPING UNIT (MOVABLE HOUSING WITH CLAMPING FUNCTION ON THE SUPPORT TUBE OF THE BASE UNIT) OF THE PRODUCT WAS INCORRECTLY POSITIONED, WHICH LED TO A SHIFT IN THE POSITION OF THE PATIENT'S SKULL AND WHICH IS WHY THE TREATING SURGEON DECIDED TO POSTPONE THE COMPLETION OF THE PROCEDURE TO ANOTHER DATE. THE REPORTER DESCRIBES THAT AFTER CAREFUL INSPECTION OF THE PRODUCT, THE TEAM CONCLUDED THAT THERE WAS AN INADVERTENT DISPLACEMENT OF THE PRODUCT'S TENSION ADJUSTMENT DEVICE, THUS REDUCING THE TENSION SETTING, WHICH ALLOWED THE CLAMPING UNIT (WHICH IS CONNECTED TO THE SKULL CLAMP FIXING THE PATIENT'S HEAD) OF THE DEVICE TO SHIFT. IN A SECOND SUBSEQUENT FEEDBACK, THE USER DESCRIBES A FURTHER USE OF THE PRODUCT CARRIED OUT ON MAY 18 WITHOUT INCIDENTS OR OTHER ANOMALIES, DURING WHICH THE INTEGRITY AND OPTIMAL FUNCTIONING OF THE PRODUCT IS CONFIRMED, THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575170 ↗
• InjuryOct 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER INFORMED US ON THE 6TH OF SEPTEMBER THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT'S HEAD FELL OUT OF THE HEADREST SYSTEM, BECAUSE THE LOCKING LEVER OF THE SYSTEM'S BASE UNIT JUMPED OPEN AFTER CLOSING. IT WAS REQUIRED CATCHING THE PATIENT'S HEAD TO PREVENT IT FROM FALLING FURTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17963182 ↗
• InjuryOct 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  CUSTOMER INFORMED US ON THE (B)(6) THAT ONE OF OUR PRODUCTS WAS INVOLVED IN A CASE IN WHICH THE PATIENT'S HEAD FELL OUT OF THE HEADREST SYSTEM, BECAUSE THE LOCKING LEVER OF THE SYSTEM'S BASE UNIT JUMPED OPEN AFTER CLOSING. IT WAS REQUIRED CATCHING THE PATIENT'S HEAD TO PREVENT IT FROM FALLING FURTHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17963181 ↗