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RecallWatchMedical Device Safety
Class IIOngoingZ-1764-2025

Contec Medical Systems Co., Ltd. recalls CMS8000 Patient Monitor

Contec Medical Systems Co., Ltd.Qinhuangdao, ChinaReported May 21, 2025 · 1 year ago
Legal News Analyst ·

Reason for recall

Patient monitor has nine identified cybersecurity vulnerabilities.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Affected products & lots

  • CMS8000 Patient MonitorUDI-DI
    UDI-DI 06945040100034.
    272 affected lots
    AX1409100187AX1410100001AX1410100014AX1410100015AX1410100024AX1410100028AX1410100030AX1410100036
    +264 moreAX1410100037AX1410100038AX1410100042AX1410100044AX1410100050AX1410100059AX1410100065AX1410100074AX1410100078AX1410100079AX1410100084AX1410100087AX1410100088AX1410100092AX1410100099AX1410100101AX1410100105AX1410100107AX1410100113AX1410100117AX1410100122AX1410100127AX1410100129AX1410100136AX1410100137AX1410100141AX1410100149AX1410100153AX1410100157AX1410100160AX1410100165AX1410100168AX1410100170AX1410100172AX1410100174AX1410100187AX1410100189AX1410100195AX1410100199AX1411100003AX1411100004AX1411100006AX1411100007AX1411100008AX1411100009AX1411100011AX1411100015AX1411100018AX1411100020AX1411100024AX1411100026AX1411100027AX1411100032AX1411100038AX1411100040AX1411100042AX1411100043AX1411100044AX1411100054AX1411100057AX1411100059AX1411100066AX1411100067AX1411100073AX1411100075AX1411100076AX1411100077AX1411100079AX1411100080AX1411100084AX1411100087AX1411100089AX1411100091AX1411100093AX1411100094AX1411100096AX1411100100AX1411100101AX1411100102AX1411100107AX1411100111AX1411100112AX1411100113AX1411100114AX1411100117AX1411100120AX1411100122AX1411100123AX1411100125AX1411100126AX1411100129AX1411100130AX1411100131AX1411100134AX1411100135AX1411100137AX1411100138AX1411100140AX1411100143AX1411100145AX1411100146AX1411100148AX1411100150AX1411100151AX1411100153AX1411100154AX1411100155AX1411100156AX1411100157AX1411100161AX1411100163AX1411100164AX1411100165AX1411100171AX1411100174AX1411100175AX1411100178AX1411100179AX1411100180AX1411100181AX1411100182AX1411100183AX1411100186AX1411100188AX1411100189AX1411100190AX1411100194AX1411100196AX1411100199AX1410100058AX1410100060AX1410100062AX1410100063AX1410100064AX1410100066AX1410100067AX1410100068AX1410100069AX1410100070AX1410100071AX1410100076AX1410100081AX1410100082AX1410100085AX1410100086AX1410100090AX1410100091AX1410100093AX1410100094AX1410100095AX1410100096AX1410100097AX1410100098AX1410100102AX1410100104AX1410100106AX1410100108AX1410100111AX1410100112AX1410100114AX1410100116AX1410100123AX1410100124AX1410100125AX1410100126AX1410100128AX1410100130AX1410100131AX1410100134AX1410100135AX1410100138AX1410100139AX1410100140AX1410100142AX1410100146AX1410100148AX1410100150AX1410100151AX1410100152AX1410100154AX1410100155AX1410100156AX1410100159AX1410100166AX1410100167AX1410100171AX1410100177AX1410100178AX1410100179AX1410100180AX1410100182AX1410100185AX1410100186AX1410100188AX1410100190AX1410100192AX1410100193AX1410100196AX1410100198AX1410100200AX1410100026AX1410100027AX1410100029AX1410100031AX1410100032AX1410100033AX1410100035AX1410100039AX1410100043AX1410100045AX1410100046AX1410100048AX1410100052AX1410100053AX1410100055AX1410100056AX1410100005AX1410100007AX1410100011AX1410100016AX1410100017AX1410100018AX1410100019AX1410100020AX1410100021AX1410100022AX1410100002AX1410100003AX1410100004AX1412300128AX1412300034AX1412300172AX142200158AX142200013AX1506300015AX1506300106AX1506300146AX1506300173AX1412200013AX1412200030AX1412200083AX1412200088AX1412200097AX1412200100AX1412200104AX1412200119AX1412200144AX1412200158AX1402200040AX1402200149AX1411100039AX1411100062AX1411100070AX1411100160AX1604200019AX1604200037AX1604200082AX1604200009AX1604200012AX1604200020AX1604200040AX1604200090AX1604200019AX1604200184

What the firm is doing

On 4/10/2025, Security Advisory Notices were sent to customers who were asked to do the following: Immediate Mitigation Actions: 1) Network segmentation. a. Implement Segmentation: Segment your network to isolate the device from other parts of the network. b. Use Firewalls: Utilize firewalls to control and monitor traffic between different segments, ensuring only authorized communications are allowed. 2) Disable the monitor network port to protect it from potential network threats. Long term mitigation action: Firm is in the process of finalizing a remediation plan and will follow-up with another Security Advisory notice once the remediation plan is finalized. Mitigations for patients and caregivers using the CMS8000 patient monitor outside a healthcare facility (i.e., in a home environment): -If the device can be safely disconnected from the internet, unplug the ethernet cable from the CMS8000 patient monitor and use only local monitoring features of the device. - If the device cannot be safely disconnected from the internet, we recommend that you stop using the CMS8000 patient monitor and contact your healthcare provider about finding an alternate patient monitor. This security Advisory notice should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred. Complete and return the response form. If you have any questions, please contact the firm at contact@contecmed.com On 5/19/2025, additional notices were distributed informing customers to contact the firm or local distributor, email at contact@contecmed.com, so they can provide a software upgrade package and installation guide.

DistributionShow details

US Nationwide distribution in the states of CA, IL, FL, KY, TX.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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