Recall Z-0169-2026 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Spacelabs Healthcare, Inc.
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-01 Software Version: N/A Product Description: 16 inch DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
| Date | Oct 16, 2025 (initiated Sep 5, 2025) |
| Status | Open, Classified |
| Reason | Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use. |
| Root cause | Device Design |
| Action | On 09/05/2025, the firm email an "URGENT MEDICAL DEVICE CORRECTION" Letter to customer informing them that the DVI cables which are used for connecting the Qube (91390) or Xprezzon (91393) to the 94267-19, 94267-L19, 94267-L17 and 94267-L15 displays, do not meet the EMI/EMC electrical safety standards specifically for electromagnetic shielding and may pose serious risks to patient safety by interfering with the operation of another device, particularly in environments where electrically sensitive medical devices are in use. Customers are instructed to acknowledge receipt and understanding of |
| Quantity | 16898 |
| Distribution | Worldwide - United States Nationwide distribution including in the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, VA, WA, WI, WY and the countries of AFG, ARE, ARG, AUS, AUT, BG |
| FDA record | Open on fda.gov |