Recall Z-1764-2025— Contec Medical Systems Co., Ltd.

Name: FDA recall Z-1764-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-10

Class II · Ongoing

Class II FDA medical device recall by Contec Medical Systems Co., Ltd., initiated 2025-04-10. It names one FDA 510(k) clearance: K101692. Product: CMS8000 Patient Monitor. Reason: Patient monitor has nine identified cybersecurity vulnerabilities..

Recalling firm: Contec Medical Systems Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2025-04-10
Firm location: Qinhuangdao, China

510(k) clearances named in this recall

1 on FDA's record

K101692 — PATIENT MONITORContec Medical System Co., Ltd.·cleared 2011-06-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CMS8000 Patient Monitor

Reason for recall

Patient monitor has nine identified cybersecurity vulnerabilities.

Data sourced from openFDA. This site is unofficial and independent of the FDA.