MACRecalls & reported problems across all models
Ge Medical Systems Information Technologies, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one MAC model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 4
We found 4 models of MAC by Ge Medical Systems Information Technologies, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Sep 17, 2020 and Sep 17, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
4 FDA recall records name at least one of these models by its device identifier, 3 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
MAC recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 29, 2026Open, Classified
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close automatically after 2 minutes of inactivity. As a result, data from a previous patient may remain on the screen and could be incorrectly associated with a subsequent patient.
Z-2876-2026 · Root cause: Software design · Recall details · FDA record ↗
- Apr 21, 2026Open, Classified
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.
Z-2306-2026 · Root cause: Software Manufacturing/Software Deployment · names 2 of these models · Recall details · FDA record ↗
- Aug 22, 2025Open, Classified
If a user incorrectly places the Acquisition Module into the Acquisition Module Holder, it can result in excessive bending and wear of the Acquisition Trunk Cable. This is visible as a damaged sheath or exposed wires. If a damaged Acquisition Trunk Cable is not recognized and removed from service, the cable can overheat with continued use.
Z-0231-2026 · Root cause: Device Design · Recall details · FDA record ↗
- Jun 28, 2019Terminated
Two issues: 1) The MAC VU360 system may intermittently display an incorrect patient ID or visit number on the screen after scanning the patient s barcode. This may result in the ECG report being assigned to the incorrect patient. 2) The MAC VU360 may have the incorrect patient demographics appear on the patient banner. This may result in the ECG report being assigned to the incorrect patient.
Z-2060-2019 · Root cause: Software design · Recall details · FDA record ↗
Most reported MAC problems
Device problems
- Device Handling Problem1
- Smoking1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
MAC models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
Recent MAC adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2020Smoking; Sparking; Device Handling Problem; Device Handling Problem
THE CUSTOMER ALLEGED A SPARK AND SMOKE OCCURRED ON THE CABLE THAT RUNS BETWEEN THE ACQUISITION MODULE (CC14) AND THE MAC VU360 WHILE CONNECTED TO A PATIENT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10546865 ↗
Other Ge Medical Systems Information Technologies, Inc. products
All Ge Medical Systems Information Technologies, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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