PlainRecordsFDA · Medical device recall
Discovery NM/CT 670 DR… and 2 more products
- Date
- Dec. 19, 2018
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Completed
- Filed by
- GE Healthcare, LLC
- Reason
- 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
3 products in this recall
Discovery NM/CT 670 DR…
- Product
- Discovery NM/CT 670 DR, model 5376204-70-56 intended for use in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.
- Quantity
- 4 units
- Codes and lots
- GTIN 00840682124393 Serial Numbers: DDRW34032, DDRX34038, DDRX34041, DDRX34045
- Recall started
- May 24, 2018
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Component change control
- What the company told customers
- The firm initiated the recall by letter on 05/24/2018. The letter explained the issue and requested the UPS(s) be disconnected from the system until the system could be repaired.
- Recall number
- Z-0606-2019
Discovery NM/CT 670 ES…
- Product
- Discovery NM/CT 670 ES, model 5376204-70-57
- Quantity
- 2 units
- Codes and lots
- GTIN 00840682123877 Serial Numbers: ESDX35013, ESDW35010
- Recall started
- May 24, 2018
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Component change control
- What the company told customers
- The firm initiated the recall by letter on 05/24/2018. The letter explained the issue and requested the UPS(s) be disconnected from the system until the system could be repaired.
- Recall number
- Z-0607-2019
Discovery NM/CT 670 Pro…
- Product
- Discovery NM/CT 670 Pro, model 5376204-70-54
- Quantity
- 1 unit
- Codes and lots
- GTIN 00840682121194 Serial Number ESDX35015
- Recall started
- May 24, 2018
- Device type
- System, Tomography, Computed, Emission
- Root cause (FDA)
- Component change control
- What the company told customers
- The firm initiated the recall by letter on 05/24/2018. The letter explained the issue and requested the UPS(s) be disconnected from the system until the system could be repaired.
- Recall number
- Z-0608-2019
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-0606-2019, Z-0607-2019, Z-0608-2019. The agency record governs; check it and the company before acting.