| Class 2 Device Recall Discovery NM/CT 670 Pro | |
Date Initiated by Firm | May 24, 2018 |
Create Date | December 13, 2018 |
Recall Status1 |
Completed |
Recall Number | Z-0608-2019 |
Recall Event ID |
81680 |
510(K)Number | K093514 |
Product Classification |
System, tomography, computed, emission - Product Code KPS
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Product | Discovery NM/CT 670 Pro, model 5376204-70-54 |
Code Information |
GTIN 00840682121194 Serial Number ESDX35015 |
Recalling Firm/ Manufacturer |
GE Healthcare, LLC 3000 N Grandview Blvd Waukesha WI 53188-1615
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For Additional Information Contact | 800-437-1171 |
Manufacturer 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. |
FDA Determined Cause 2 | Component change control |
Action | 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. |
Quantity in Commerce | 1 unit |
Distribution | CA, DC, OH, UT, WI, Canada |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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510(K) Database | 510(K)s with Product Code = KPS
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