Z-0168-2026Class II

Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number...

Name: Z-0168-2026 Brand Name: Branding is not applied to this product. Product Name: DVI display cables Model/Catalog Number...
Creator: Spacelabs Healthcare, Inc.
Published: 2025-09-05
License: https://open.fda.gov/license/

GE Healthcare / initiated 2025-09-05 / Open, Classified / root cause: design

FDA source

Spacelabs Healthcare, Inc. began a recall of 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... on 2025-09-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0168-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-05
Posted: 2025-10-16
Recalling firm: GE Healthcare
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
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: design
FDA 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 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: [email protected]
Quantity in commerce: 820
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.
Product codes and lots: Lot Code: UDI-DI for products that are used with the display cables. (01)10841522131479 (Xprezzon), (01)10841522131455 (Qube)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0168-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0167-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0168-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16
Z-0169-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-10-22	2025-10-16

Product code MHX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)