CT SCANNER, NL5000 0-NL5000-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10815411020335), received between Apr 29, 2019 and Jun 4, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Battery Problem” (1 report).

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

1 other recall cover devices cleared under the same FDA submission (K171183); they may or may not involve this specific model.

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 18, 2026.

Recalls naming this device

1. Jun 6, 2023Class IIOpen, Classified

   1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain contaminated boards, which may impact the ability to power on the device, this could lead to delay for patient treatment

   Z-2068-2023 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Battery Problem

  THE SCANNER WAS STUCK IN THE ICU HALLWAY CAUSING DELAY IN THE TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386905 ↗
• MalfunctionApr 22, 2026Appropriate Device Problem Term/Code Not Available

  THE TABLET SCREEN GOES WHITE DURING SCANS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24950701 ↗
• MalfunctionMar 17, 2026Mechanical Problem

  WHEN TRYING TO SHOOT X-RAYS, THEY ARE NOT GETTING FIRED AND SHOWING AN ERROR ON THE SCREEN, CAUSING A DELAY IN THE PATIENT PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24619181 ↗
• MalfunctionFeb 4, 2026Appropriate Device Problem Term/Code Not Available

  THE WHEELS ARE NOT MOVING DURING ACQUISITION. A PIECE OF RUBBER POPPED OFF THE WHEEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24263838 ↗
• MalfunctionJul 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE SYSTEM WAS UNABLE TO SCAN, WHICH CAUSED A DELAY IN THE PATIENT'S TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385671 ↗
• MalfunctionApr 21, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE SYSTEM WAS DISPLAYING AN ERROR MESSAGE AND WOULD NOT SCAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21878341 ↗
• MalfunctionMar 4, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THE SYSTEM TABLET WAS TURNED OFF DURING A SCAN, WHICH REQUIRED A RESCAN OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21521359 ↗
• MalfunctionJan 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  THE SCANNER ABORTED A SCAN, WHICH DELAYED THE DIAGNOSIS AND TREATMENT OF A PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186622 ↗
• MalfunctionOct 30, 2023Inadequate or Insufficient Training; Use of Device Problem; Inadequate or Insufficient Training; Use of Device Problem

  THE CUSTOMER REPORTED THAT A CT TECH BROKE THEIR HAND WHILE DRIVING THE OMNITOM.

  Patient problems: Bone Fracture(s)

  MAUDE report 18029995 ↗
• MalfunctionJul 25, 2019Electrical Shorting; Electrical Shorting

  THE OMNITOM CT SYSTEM WAS MOVED TO NICU FOR AN ORDERED CT. THE SCANNER STOPPED MOVING AND THE SCREEN SAID 'LOCKED SCANNER'. THE SCAN WAS NOT ABLE TO BE PERFORMED AND THE MACHINE WAS BLOCKING THE PATIENT ROOM ENTRANCE. THE CT SCANNER WAS MOVED OUT OF THE WAY AS IT WAS BLOCKING THE PATIENT'S DOORWAY. AFTER KNOWING THAT THE SCAN WAS NOT GOING TO BE COMPLETED, THE PATIENT WAS RETURNED TO THE NORMAL BED POSITIONING. CUSTOMER REPORTED DIFFICULTY COMMUNICATING WITH MFG. CUSTOMER SERVICE AT THE TIME AND UNSUCCESSFUL TROUBLESHOOTING. NO USER OR PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8828078 ↗
• MalfunctionMay 13, 2019Human-Device Interface Problem; Human-Device Interface Problem

  DURING NAVIGATION OF THE OMNITOM CT SYSTEM, TECHNOLOGIST WAS UNABLE TO GET THE OMNITOM TO TURN OR DO ANYTHING OTHER THAN GO BACKWARD. THIS RESULTED IN THE TECHNOLOGIST GETTING BACKED UP AGAINST A SINK. AFTER SEVERAL MINUTES THE TECHNOLOGIST WAS ABLE TO GET THE SYSTEM TO TURN HOWEVER THE CT SYSTEM KEPT STOPPING WHILE TRANSPORTING IT TO THE STORAGE LOCATION. NO PATIENTS WERE HARMED A RESULT OF THIS INCIDENT HOWEVER THE TECHNOLOGIST HAD SOME BRUISING.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8605695 ↗
• MalfunctionApr 29, 2019Unintended Movement; Patient Device Interaction Problem; Unintended Movement; Patient Device Interaction Problem

  CUSTOMER STATED THAT THE OMNITOM CT SYSTEM JUMPED FORWARD WHEN DRIVING. SEVERAL ATTEMPTS TO DRIVE THE SYSTEM FAILED. THE CT SYSTEM WAS LEFT ON AND LODGED IN THE CORNER OF THE STORAGE ROOM AS THE SYSTEM WAS DRIVING ERRATICALLY. NO PATIENTS OR STAFF WERE HARMED AS A RESULT OF THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8559955 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171183. One submission often covers many models, so check the product and lot details in each record.

• Z-2772-2020 · Jul 15, 2020 · Terminated
  OmniTom Computed tomography x-ray system, Model NL5000, all NL5000 systems with software version before 05.01.01 - Product Usage: is intended to be used for x-ray computed tomograp