CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
Branding is not applied to this product DVI display cables recalled
Spacelabs Healthcare is recalling Branding is not applied to this product DVI display cables, distributed nationwide in the US. The recall was initiated on 5 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0168-2026
- FDA event ID
- 97616
- Recalling firm
- Spacelabs Healthcare, Snoqualmie, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Sep 2025
- FDA classified
- 16 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Medical Software
Timeline
| 5 Sep 2025 | Recall initiated by company | |
| 16 Oct 2025 | Classified by FDA | +41 days |
| 22 Oct 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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.
Nationwide AlaskaAlabamaArizonaCaliforniaColoradoConnecticutDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaineMichigan
Questions about this recall
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.
Which lots are affected?
Lot Code: UDI-DI for products that are used with the display cables. (01)10841522131479 (Xprezzon), (01)10841522131455 (Qube)
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 97616This product is part of a recall event; the main page for the event is Branding is not applied to this product DVI display cables recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Branding is not applied to this product DVI display cables recalled | Spacelabs Healthcare | Device Malfunction | Nationwide | |
| CLASS II | Branding is not applied to this product DVI display cables recalled | Spacelabs Healthcare | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | Sentinel V11 recalled by Spacelabs Healthcare | Spacelabs Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Branding is not applied to this product DVI display cables recalled | Spacelabs Healthcare | Device Malfunction | Nationwide |
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| Device | ANNOUNCED | BMC Luna G3 APAP recalled by BMC MedicalBMC | BMC Medical | Device Malfunction | Nationwide |