The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2306-2026·Announced 2026-06-10

GE MAC 5 ECG systems may link data to the wrong patient

GE MAC 5 A4 and A5 Resting ECG Analysis Systems are being recalled because a development software version was released that can associate clinical information with the wrong patient.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall where clinical data may be attached to the wrong patient and affect decision-making, a risk of harm with no injuries reported.

Plain-English summary

The MAC 5 A4 Resting ECG Analysis System (855001-001) and MAC 5 A5 Resting ECG Analysis System (8855002-001), running software version 3.00, are being recalled. The action covers 16 units.

Software in development was inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient, which could impact clinical decision-making. The FDA classified the action as Class II.

Distribution was worldwide, including nationwide in the United States with units in Florida and Georgia. The systems are used in healthcare settings rather than sold to consumers.

Facilities should identify affected systems using the model numbers, UDI-DI codes and software version above and follow the instructions issued by GE HealthCare.

The recalled product

Product
MAC 5 A4 Resting ECG Analysis System 855001-001; MAC 5 A5 Resting ECG Analysis System 8855002-001. Electrocardiograph
Manufacturer
GE Medical Systems China Co., Ltd.
Category
Medical Device — Electrocardiograph
Hazard
Affected units
16

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Software version 3.00 855001-001
  • UDI-DI 00195278276070 8855002-001
  • UDI-DI 00195278276124

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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