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Disposable MRI Kit for 65/115 MR Injector System SSQK 65/115VS (UDI 00616258005423)Recalls & reported problems

Bayer Medical Care Inc. · Spectris Solaris MR Kit (Includes 65 ML Qwik-Fit Syringe, 115 ML Qwik-Fit Syringe for Saline, 1 large spike, 1 small spike for contrast, 96" low pressure tubing with T-connector and Check Valve) (MR - SOLARIS SYRINGE KIT, 65/115ML) (60728567) · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00616258005423), received between Oct 9, 2017 and Jan 24, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Manufacturing, Packaging or Shipping Problem2
  • Device Contamination with Chemical or Other Material1

Patient problems

  • No Patient Involvement2
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionJan 24, 2020Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    THE CUSTOMER REPORTED THE FOLLOWING: THE CUSTOMER OBSERVED A FOREIGN MATERIAL IN THE SALINE SYRINGE BARREL OF A SSQK 65/115VS SYRINGE KIT. NO INJURY OR ADVERSE EVENT WAS REPORTED.

    Patient problems: No Patient Involvement

    MAUDE report 9626823 ↗
  • MalfunctionNov 8, 2019Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

    THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING A SSQK 65/115VS SYRINGE KIT, A HAIR WAS OBSERVED WITHIN THE SYRINGE BARREL. THERE WAS NO ADVERSE EVENT OR INJURY.

    Patient problems: No Patient Involvement

    MAUDE report 9296430 ↗
  • MalfunctionOct 9, 2017Device Contamination with Chemical or Other Material

    THE CUSTOMER REPORTED THE FOLLOWING: AFTER OPENING THE MR DISPOSABLE KIT AND UPON INSPECTION, THEY SAW A FOREIGN BODY WITHIN THE LPCT (LOW PRESSURE CONNECTOR TUBING). THE CUSTOMER ELECTED NOT TO USE THE TUBING. NO INJURY OR ADVERSE EVENT WAS REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6928180 ↗

Other Injector And Syringe, Angiographic devices

All Injector And Syringe, Angiographic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.