Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
- Company
- Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
- Recall Initiated
- July 30, 2019
- Terminated
- May 17, 2022
- Recall Number
- Z-1075-2022
- Quantity
- 4
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.
Distribution
US Nationwide distribution in the state of TX.
Lot / Code Info
DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015
Root Cause
Software change control
Action Taken
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.