Z-0608-2019 Class II
FDA device recall Z-0608-2019 was initiated by GE Healthcare, LLC on May 24, 2018 and is designated Class II. Reason for recall: When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these… Affected quantity: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 19, 2018
- Initiation Date
- May 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Discovery NM/CT 670 Pro, model 5376204-70-54
Reason for Recall
When your system was installed, the Main disconnect switch, EPO button on the A1 panel, and Remote EPO button(s) (outside of the A1 panel) may not have been wired correctly which could result in these not shutting off all power to the entire system as intended, resulting in a potential electric hazard.
Distribution Pattern
CA, DC, OH, UT, WI, Canada
Code Information
GTIN 00840682121194 Serial Number ESDX35015
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0608-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026