FDA Medical devices recall ·
CMS8000 Patient Monitor recall
- Recall number
- Z-1764-2025
- Date
- (initiated April 10, 2025)
- Company / brand
- Contec Medical Systems Co., Ltd.
Economic And, Qinhuangdao, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 7773
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
CMS8000 Patient Monitor
Why was it recalled?
Patient monitor has nine identified cybersecurity vulnerabilities.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 06945040100034. UDI-DI/Serial Numbers: AX1409100187, AX1410100001 AX1410100014 AX1410100015 AX1410100024 AX1410100028 AX1410100030 AX1410100036 AX1410100037 AX1410100038 AX1410100042 AX1410100044 AX1410100050 AX1410100059 AX1410100065 AX1410100074 AX1410100078 AX1410100079 AX1410100084 AX1410100087 AX1410100088 AX1410100092 AX1410100099 AX1410100101 AX1410100105 AX1410100107 AX1410100113 AX1410100117 AX1410100122 AX1410100127 AX1410100129 AX1410100136 AX1410100137 AX1410100141 AX1410100149 AX1410100153 AX1410100157 AX1410100160 AX1410100165 AX1410100168 AX1410100170 AX1410100172 AX1410100174 AX1410100187 AX1410100189 AX1410100195 AX1410100199 AX1411100003 AX1411100004 AX1411100006 AX1411100007 AX1411100008 AX1411100009 AX1411100011 AX1411100015 AX1411100018 AX1411100020 AX1411100024 AX1411100026 AX1411100027 AX1411100032 AX1411100038 AX1411100040 AX1411100042 AX1411100043 AX1411100044 AX1411100054 AX1411100057 AX1411100059 AX1411100066 AX1411100067 AX1411100073 AX1411100075 AX1411100076 AX1411100077 AX1411100079 AX1411100080 AX1411100084 AX1411100087 AX1411100089 AX1411100091 AX1411100093 AX1411100094 AX1411100096 AX1411100100 AX1411100101 AX1411100102 AX1411100107 AX1411100111 AX1411100112 AX1411100113 AX1411100114 AX1411100117 AX1411100120 AX1411100122 AX1411100123 AX1411100125 AX1411100126 AX1411100129 AX1411100130 AX1411100131 AX1411100134 AX1411100135 AX1411100137 AX1411100138 AX1411100140 AX1411100143 AX1411100145 AX1411100146 AX1411100148 AX1411100150 AX1411100
Distribution
US Nationwide distribution in the states of CA, IL, FL, KY, TX.
States: California Florida Illinois Kentucky Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1764-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.