Food, drugs, devices › GE Medical Systems China Co., Ltd.
Device recall: MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
FDA enforcement event 98917 is a device recall by GE Medical Systems China Co., Ltd. of Wuxi, initiated 21 Apr 2026 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. GE Medical Systems China Co., Ltd. has 7 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Medical Systems China Co., Ltd., Wuxi, China.
Reason for recall
"Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making."
Distribution
"Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2306-2026 | MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph | 16 | Class II | Ongoing | 10 Jun 2026 |
Context
Other enforcement events for GE Medical Systems China Co., Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 14 Nov 2025 | GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Care | Device | Class I | 3 |
| 16 May 2025 | GE Healthcare LOGIQ F R3 Ultrasound System, Model/Catalog Number 5943263, diagnostic ultrasound system | Device | Class II | 2 |
| 21 Mar 2025 | GE Healthcare CARESTATION 620 A1, Model/REF Number 1012-9620-000. anesthesia systems | Device | Class I | 15 |
| 8 Sep 2023 | F2-01 Frame, physiological patient monitor (with arrhythmia detection or alarms) | Device | Class II | 1 |
| 24 Jul 2018 | GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems | Device | Class II | 3 |
| 11 Oct 2017 | Carestation 620 A1, Carestation 650 A1, and Carestation 650c A1 | Device | Class II | 2 |
All 7 events for GE Medical Systems China Co., Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This could impact clinical decision-making."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide distribution in the states of Florida and Georgia. The countries of India, Italy, Republic of Korea, and United Kingdom."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.