Breast BI 7 MR Coil Set 3T 10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04251269207389), received between Apr 23, 2026 and Aug 25, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  This is an initial 30-day report. This report is one of five related reports concerning local skin injuries reported in association with breast biopsy procedures performed using a NORAS Breast BI 7 biopsy coil, serial number (b)(6). The manufacturer's investigation has been completed, and the final investigation results are included in this initial report.The manufacturer was informed of this event as part of a cluster of five alleged local skin injuries occurring during the period from (b)(6) 2025 through (b)(6) 2026. No individual clinical questionnaire, photographs, procedure date, patient age, patient weight, detailed description of the injury, treatment information, or patient outcome information were made available for this specific patient. Therefore, the circumstances and clinical severity of this individual event could not be independently confirmed.The manufacturer completed its investigation of this event and the four related reports. The investigation included review of the available customer information, clinical information available for the related cases, imaging and system data, device history, service information, quality assurance testing, RF-related testing, and

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50437731 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50437730 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  This is follow-up report 1 and the final investigation update for manufacturer report 3004929307-2026-00003. This report is one of five related reports concerning local skin injuries reported in association with breast biopsy procedures performed using a NORAS Breast BI 7 biopsy coil, serial number (b)(6).Additional information obtained during the investigation established that the event occurred on (b)(6) 2025. The patient was female; the patient's age and weight were not available. The injury was described by the customer as a second-degree burn. The skin injury was noticed approximately two days after the procedure. No additional medical treatment was documented, and complete recovery was reported after approximately one week.The patient underwent a breast biopsy in the prone, head-first position with symmetrical positioning and both arms placed in the Superman position. The left breast was biopsied. The procedure was performed using the Breast BI 7 biopsy coil with the standard grid and an EnCor/Enspire MRI vacuum biopsy system and associated accessories.The manufacturer completed its investigation of this event and the four related reports. The investigation included review of

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24964883 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  This is follow-up report 1 and the final investigation update for manufacturer report 3004929307-2026-00002. This report is one of five related reports concerning local skin injuries associated with breast biopsy procedures performed at the same user facility using the same Breast BI 7 MR Coil, serial number (b)(6).The event occurred on (b)(6)2026. The patient was a 56-year-old female, 160 cm in height and weighing 65 kg. The reported skin lesion was located on the left breast above the nipple and measured approximately 6 cm by 2 cm. Blistering was observed within 24 hours, followed by ulceration. A lumpectomy was performed five days after the biopsy. The available records do not establish whether the lumpectomy was part of the treatment of the skin lesion.The procedure was performed in the prone, feet-first position with the arms in the Superman position. The left breast was biopsied. No contact with the inner wall of the MR bore and no skin-to-skin contact were reported. The patient did not report a sensation of heat during the procedure. The manufacturer's investigation has been completed. The investigation did not establish a device-related root cause. The final evaluation is p

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24964862 ↗
• InjuryApr 23, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS REPORT IS 1 OF 5 REPORTS ASSOCIATED WITH THE SAME DEVICE MODEL AND USER FACILITY. ON MARCH 24, 2026, THE MANUFACTURER WAS INFORMED OF A CLUSTER OF INCIDENTS. THE CUSTOMER ALLEGED THAT UP TO 5 PATIENTS SUSTAINED SUPERFICIAL BURNS DURING BREAST BIOPSY PROCEDURES BETWEEN (B)(6) 2025 AND (B)(6) 2026. THE EXAMINATIONS WERE PERFORMED USING THE NORAS BREAST BI 7 COIL (SN (B)(6)) IN CONJUNCTION WITH A SIEMENS MAGNETOM VIDA MRI SCANNER. PRELIMINARY QUALITY ASSURANCE (QA) CHECKS AND MR TESTING OF THE INVOLVED COIL (SN (B)(6)) CONDUCTED BY THE SYSTEM INTEGRATOR DID NOT REVEAL ANY FAULTS OR MALFUNCTIONS. HOWEVER, COMPREHENSIVE LABORATORY TESTING AND TECHNICAL EVALUATION BY THE LEGAL MANUFACTURER ARE STILL PENDING. THE ROOT CAUSE OF THE REPORTED BURNS REMAINS UNCONFIRMED. WE ARE ACTIVELY REVIEWING THE AVAILABLE CLINICAL DATA TO DETERMINE IF THE DEVICE CONTRIBUTED TO THE EVENT. AN UPDATED FOLLOW-UP REPORT WILL BE PROVIDED ONCE THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 24964839 ↗