Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-01
FDA device recall Z-0167-2026 · posted 2025-10-16 · Open, Classified
Recall details
- Recalling firm
- Spacelabs Healthcare, Inc.
- Reason for recall
- 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.
- Action taken
- 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 this notification and request replacement cables as soon as possible, however no later than 31-Dec-2025. Do not replace cables while a patient is admitted to the monitor to mitigate any potential disruption in active patient monitoring. Any affected cables not currently in use should not be placed into service. For questions and/or assistance with this recall, contact: Spacelabs Technical Support Spacelabs Healthcare, Inc 35301 SE Center Street Snoqualmie, WA 98065 1-800-522-7025 and select 2 for Technical Support Email: Support@spacelabs.com
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 8179
- 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,
- Date initiated
- 2025-09-05
- Date posted
- 2025-10-16
- Location
- Snoqualmie, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390 (K120616) | Spacelabs Medical, Inc. | 2012-03-29 |
| SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930) (K112962) | Spacelabs Medical, Inc. | 2011-11-02 |