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U.S. Department of Health and Human Services

Class 2 Device Recall uDR 592h, uDR 596i

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 Class 2 Device Recall uDR 592h, uDR 596isee related information
Date Initiated by FirmJuly 30, 2019
Create DateMay 12, 2022
Recall Status1 Terminated 3 on May 17, 2022
Recall NumberZ-1075-2022
Recall Event ID 90104
510(K)NumberK181413 
Product Classification System, x-ray, stationary - Product Code KPR
ProductDigital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Code Information DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015
FEI Number 3011015597
Recalling Firm/
Manufacturer		 Shanghai United Imaging Healthcare Co., Ltd.
No. 2258 Chengbei Rd, Jiading Ind.
Shanghai China
Manufacturer Reason
for Recall		X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
FDA Determined
Cause 2		Software change control
ActionOn 07/30/19, Customer Notification Letters started being distributed to customers. Customers were asked to contact the firm if they found an inconsistency between the protocol name and the positioning image. The following phone numbers were provided: (855) 221-1552 (toll free) or (832) 699-2799 (direct). The firm issued Field Correction Instructions to Service Engineers to modify the protocol name of Flexion and Extension on C-Spine & L-Spine with the corrected guidelines. In addition, the firm committed to permanently fix impacted systems with a software update.
Quantity in Commerce4
DistributionUS Nationwide distribution in the state of TX.
Total Product Life CycleTPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = KPR
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