X-ray Imaging Systems Have Reversed Spine Positioning Labels
Shanghai United Imaging's digital X-ray systems may display reversed spine positioning labels, potentially causing misdiagnosis and unnecessary repeat radiation exposure for patients.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The reversed labeling represents a significant risk-of-harm by enabling diagnostic errors that could lead to unnecessary patient radiation exposure, meeting the rubric criterion for High severity.
Plain-English summary
Shanghai United Imaging Healthcare Co., Ltd. is recalling 4 Digital Medical X-ray Imaging Systems (Models uDR 596i and uDR 592h) due to reversed positioning image and protocol labels for cervical spine (C-Spine) and lumbar spine (L-Spine) flexion and extension views.
The reversed labeling can cause healthcare providers to misinterpret imaging and make incorrect diagnostic decisions. Patients may then undergo unnecessary repeat radiation exposure if the initial images are incorrectly labeled and require retaking.
Affected systems were distributed nationwide, primarily in Texas. Healthcare facilities using these systems should immediately contact Shanghai United Imaging Healthcare Co., Ltd. or the FDA to report any issues and receive corrective updates.
The recalled product
- Product
- Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
- Manufacturer
- Shanghai United Imaging Healthcare Co., Ltd.
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- DI/GTIN: 06971576833023
- Serial Numbers: 270012
- 270013
- 270014
- 270015
Distribution
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