Z-0169-2026 Class II Ongoing
FDA device recall Z-0169-2026 was initiated by Spacelabs Healthcare, Inc. on September 5, 2025 and is designated Class II. 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 t… The recall status is ongoing. Affected quantity: 16898.
Recall Details
- Product Type
- Devices
- Report Date
- October 22, 2025
- Initiation Date
- September 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 16898
Product Description
Reason for Recall
Distribution Pattern
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.