| Class 2 Device Recall SIGNA Architect | |
Date Initiated by Firm | August 26, 2021 |
Date Posted | October 16, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0133-2022 |
Recall Event ID |
88665 |
510(K)Number | K160618 K163331 K202966 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
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Product | SIGNA Architect nuclear magnetic resonance imaging system |
Code Information |
Software version DV29.1; and DV28.4 (F), DV27.3 (T) (China only) |
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 | Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images. |
FDA Determined Cause 2 | Software design |
Action | GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer.
In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator. |
Quantity in Commerce | 2 devices |
Distribution | Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico
OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK |
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. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = LNH 510(K)s with Product Code = LNH
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