Siemens Pro.specta Emission CT Systems Sensor Issue Reduces Image Resolution
Siemens Pro.specta CT imaging systems may produce reduced image quality due to sensors triggering earlier than expected, potentially affecting diagnostic accuracy. Affected units were distributed across the US and internationally.
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: This Class II medical device recall affects diagnostic imaging quality in a system designed for patient imaging. While no illnesses or injuries have been reported, reduced image resolution in diagnostic CT imaging creates a risk of harm through missed or delayed diagnoses, qualifying it as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Siemens Pro.specta Emission Computed Tomography (CT) Systems, including the Symbia Pro.specta Q3 (Model 11364751), Symbia Pro.specta X3 (Model 11364752), and Symbia Pro.specta X7 (Model 11364753) are being recalled. These systems were manufactured with SLD (short-linear drive) look-ahead optical sensor assemblies using software version VA20A. A total of 108 systems are affected.
During whole-body planar scans with auto-contour enabled, the SLD look-ahead sensors may trigger earlier than expected. This causes detector positioning to move further from the patient than intended, resulting in reduced image resolution.
Affected systems were distributed to healthcare facilities in the United States (Idaho, Kansas, Massachusetts, New Hampshire, Ohio, Texas, and Virginia) and internationally to Argentina, Australia, Austria, Belgium, Canada, Colombia, Denmark, Finland, France, Germany, Hong Kong, Israel, Italy, Japan, Netherlands, Portugal, Singapore, Switzerland, Turkey, United Arab Emirates, and the United Kingdom.
Healthcare providers with affected systems should contact Siemens Medical Solutions USA, Inc. for information about the recall and available corrective actions. Specific serial numbers and UDI-DI numbers have been identified for each model.
The recalled product
- Product
- The following Pro.specta Emission Computed Tomography Systems that were manufactured with an SLD Look Ahead Optical Sensor Assembly: (a) Symbia Pro.specta Q3, Model 11364751; (b) Symbia Pro.specta X3, Model 11364752; (c) Symbia Pro.specta X7, Model 11364753.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- image-resolution-degradation
- detector-positioning-error
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 (20)
- Software version VA20A. (a) Serial numbers 100201
- 100202
- 100203
- 100204
- 100205
- 100206
- 100207
- 100209
- 100208
- 100210
- 100212
- 100211
- 100213
- 100215
- 100217
- 100219
- 100218
- 100220
- 100221
- and 100224
Distribution
Distributed in 7 states:
- ID
- KS
- MA
- NH
- OH
- TX
- VA
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