Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number: 012-0893-0
Summary
The FDA issued a Class II for Brand Name: Branding is not applied to this product. Product Name: DVI display by Spacelabs Healthcare, Inc.. Reason: Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose seri.
Details
Source
Device Recall
External ID
Z-0169-2026
Action Date
2025-10-22
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: Lot Code: UDI-DI for products that are used with the display cables. (01)10841522131479 (Xprezzon), (01)10841522131455 (Qube)
Quantity Affected: 16898
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-05
Company
Snoqualmie, WA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 237 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Spacelabs Healthcare, Inc. has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Spacelabs Healthcare, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Spacelabs Healthcare, Inc. have FDA actions?
Spacelabs Healthcare, Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0169-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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