Achieva Achieva 1.5TRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00884838055292), received between Sep 24, 2021 and Apr 17, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 reports).

3 FDA recall records name this device's identifier, 3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Aug 21, 2026Class IIOpen, Classified

   A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system memory.

   Z-3232-2026 · Root cause: Software design · Recall details · FDA record ↗

2. Jan 3, 2024Class IIOpen, Classified

   The Quadrature Body Coil (QBC) seal adhesive may fail, creating sharp edges that may come in contact with patients. If the QBC seal becomes loose during the scanning process, the risk to the patient may include skin abrasions, bruises, lacerations, hair loss/entanglement, and tissue injury.

   Z-0945-2024 · Root cause: Process control · Recall details · FDA record ↗

3. Oct 23, 2023Class IIOpen, Classified

   Potential component failure in the Gradient Coil could product smoke and/or fire.

   Z-0389-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS BROKEN. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24906930 ↗
• MalfunctionJul 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE RUBBER SEAL WAS COMING LOOSE. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22380555 ↗
• MalfunctionMay 30, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) BORE SEAL WAS LOOSE AND HANGGING. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22112396 ↗
• MalfunctionApr 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS MISSING. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS MISSING IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21924597 ↗
• MalfunctionMar 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) IN BORE WAS DAMAGED(BROKEN). THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED(BROKEN) IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21570698 ↗
• MalfunctionJan 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE RUBBER INSIDE THE GANTRY (QUADRATURE BODY COIL (QBC) SEAL) WAS MOVED (LOOSE). THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS LOOSE, IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21188706 ↗
• MalfunctionNov 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE GANTRY SEALING WAS FALLING. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS LOOSE IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20663932 ↗
• MalfunctionSep 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PHILIPS RECEIVED A REPORT THAT THE QUADRATURE BODY COIL (QBC) SEAL WAS LDAMAGED. THIS SEAL IS USED FOR PROTECTION, TO AVOID THE PATIENT FROM POTENTIALLY CONTACTING THE SHARP EDGES OF THE MAGNET COVERS. IF THIS SEAL IS DAMAGED IT IS LIKELY THAT THIS COULD LEAD TO SERIOUS INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20178377 ↗
• InjuryMar 9, 2022Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT ON A HEATING INCIDENT ON AN ACHIEVA 1.5T MR SYSTEM. A MALE PATIENT WAS POSITIONED FEET FIRST SUPINE TO UNDERGO A KNEE EXAMINATION WITH THE SENSE-KNEE-8 COIL. PATIENT REPORTED BLISTER ON THE LEFT THIGH ONE HOUR AFTER THE EXAMINATION.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 13709248 ↗
• InjurySep 24, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  PHILIPS RECEIVED A REPORT THAT A TECHNICIAN WAS INJURED DURING MAINTENANCE WORK ON AN ACHIEVA 1.5T MR SYSTEM. AN ATTRACTION INCIDENT TOOK PLACE CAUSING FRACTURES TO FINGERS.

  Patient problems: Bone Fracture(s)

  MAUDE report 12525091 ↗