Recall Z-0168-2026— Spacelabs Healthcare, Inc.
Class II · Ongoing
Class II FDA medical device recall by Spacelabs Healthcare, Inc., initiated 2025-09-05. It names 2 FDA 510(k) clearances: K120616, K112962. Product: Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393. 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..
- Recalling firm
- Spacelabs Healthcare, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-09-05
- Firm location
- Snoqualmie, WA, United States
510(k) clearances named in this recall
2 on FDA's record- K120616 — SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
- K112962 — SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0895-12 Software Version: N/A Product Description: 12 foot DVI-I to DVI-I male/male display cable. Component: Yes, the cable is an external display cable used with the 91390 and 91393
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.