- Recalling firm
- Nihon Kohden America LLC
- Reason for recall
- Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.
- Affected products (lot / model / serial)
- Lot Code: CNS-6201 (PU-621RA), SW versions: 01-03, 01-04, 01-05, 01-06, 02-10, 02-11, and 02-40
- Units affected
- 808
- Distribution pattern
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN. KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NL, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, VT, QA, WA, WI, WV and WY.
- Firm location
- Irvine, CA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0089-2027
- Recall initiated
- September 8, 2026
- FDA classification date
- October 6, 2026
- FDA report date
- October 14, 2026
- FDA event ID
- 99549
- Last updated on HTM Vibe
- October 21, 2026