Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h

FDA Recall Z-1075-2022 · Posted None

Recalling FirmShanghai United Imaging Healthcare Co., Ltd.
Recall StatusTerminated
Product CodeKPR
Date Initiated2019-07-30
Date Terminated2022-05-17
Product Quantity4

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.

Firm Action

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.

Root Cause

Software change control

Distribution Pattern

US Nationwide distribution in the state of TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K181413uDR 592h, uDR 596iShanghai United Imaging Healthcare Co., Ltd. · 2018-06-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑