Q.namix T fluoroscopy systems recalled over unflipped and mismatched images
Siemens is recalling 7 units of the LUMINOS Q.namix T fluoroscopic X-ray system because ortho images may not be flipped as preset and an image of a previous patient may be processed.
What this means for you
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: Scored 3 under the risk-of-harm criterion: the firm states images may not be flipped as preset and a previous patient's image may be processed, and no injuries are reported.
Plain-English summary
The interventional fluoroscopic X-ray system LUMINOS Q.namix T, Siemens Material Number 11574003, with software version VB10D-SP02, is being recalled by Siemens Medical Solutions USA, Inc.
The record states that ortho images acquired with preset automatic horizontal flip are not flipped, and that when acquiring single images there is the possibility that an image of a previous patient may be processed.
The record lists 7 units under UDI-DI 04056869993980, with serial numbers recorded in the enforcement record. Distribution was worldwide, including nationwide in the United States across Alaska, California, Illinois, Minnesota, New York, Oregon, Virginia and Wisconsin, and other countries listed in the record. The FDA has classified the action as Class II.
An unflipped image or an image belonging to a previous patient is content a clinician reads. The enforcement record reports no injuries. Facilities should follow Siemens' instructions.
The recalled product
- Product
- Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Fluoroscopy
- Affected units
- 7
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 (9)
- Siemens Material Number (SMN): 11574003
- UDI-DI: 04056869993980
- Serial Numbers: 170013
- 170022
- 170023
- 170021
- 170020
- 170025
- 170026
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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