Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

F2-01 Frame Recalled by GE Medical Systems China Co., Ltd. Due to There is a potential interruption of data communication...

Date: September 8, 2023
Company: GE Medical Systems China Co., Ltd.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Medical Systems China Co., Ltd. directly.

Affected Products

F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms)

Quantity: 1638 units

Why Was This Recalled?

There is a potential interruption of data communication between E-modules inserted in the F2-01 Frame and CARESCAPE ONE and CARESCAPE Canvas 1000 patient monitors if the F2-01 Frame has not been powered down within the last 120 days.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About GE Medical Systems China Co., Ltd.

GE Medical Systems China Co., Ltd. has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report