Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Brand
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
Lot Codes / Batch Numbers
DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013, 270014, 270015
Products Sold
DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015
Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China is recalling Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h due to 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 b. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026