FDA Medical devices recall ·
Branding is not applied to this product recall
- Recall number
- Z-0168-2026
- Date
- (initiated September 5, 2025)
- Company / brand
- Spacelabs Healthcare, Inc.
35301 Se Center St, Snoqualmie, WA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 820
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: UDI-DI for products that are used with the display cables. (01)10841522131479 (Xprezzon), (01)10841522131455 (Qube)
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, BGD, BHR, BOL, BRA, BRN, CAN, CHE, CHL, CHN, COL, CRI, CYP, CZE, DOM, DZA, ECU, EGY, ESP, FRA, GBR, GRC, GTM, GUM, HKG, IDN, IND, IRL, IRN, ISR, ITA, JOR, KWT, LBN, MAR, MEX, MYS, NLD, NZL, OMN, PAK, PAN, PER, PHL, PLS, POL, PRI, PRT, PRY, QAT, ROM, SAU, SGP, SLV, SRB, THA, TTO, TUN, TUR, TWN, VNM.
States: Alaska Alabama Arizona California Colorado Connecticut Delaware Florida Georgia Iowa Idaho Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi Montana North Carolina Nebraska New Hampshire New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania Puerto Rico Rhode Island South Carolina South Dakota Tennessee Texas Virginia Washington Wisconsin Wyoming
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0168-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.