Siemens Symbia T Series SPECT + CT Recall for Bearing Failure Risk
Siemens Medical Solutions is recalling 1,109 Symbia T Series SPECT + CT systems because linear bearing cars may fail, allowing ball bearings to fall out.
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: The recall involves a mechanical defect in a medical device that could lead to injury or equipment damage, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 1,109 units of the Symbia T Series SPECT + CT camera systems. The recall is due to a potential failure of the linear bearing cars that support and move the detectors horizontally and vertically. If these bearing cars fail, ball bearings may fall out.
The affected systems are distributed worldwide, including the United States, Puerto Rico, and numerous international locations. The specific serial numbers and material numbers for the affected units are listed in the official recall documentation.
Hospitals and medical facilities should contact Siemens Medical Solutions USA, Inc. to arrange for inspection and repair of the affected systems. Patients should consult their healthcare providers regarding any imaging studies performed on these devices.
The recalled product
- Product
- Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV. 2) CT: The CT…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 1,109
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)
- Material Number 10275007
- Serial Numbers 1001
- 1006
- 1007
- 1032
- 1053
- 1104
- 1134
- 1012
- 1226
- 1014
- 1015
- 1284
- 1024
- 1034
- 1055
- 1060
- 1064
- 1038
- 1039
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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