Siemens Symbia CT Systems Recalled for Internal Component Damage
Siemens Medical Solutions is recalling 295 Symbia T and T2 CT systems because a component may come loose and damage the equipment.
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 is classified as FDA Class II, and the source confirms reports of equipment damage. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High (3).
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 295 Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies. The recall covers units distributed worldwide, including the United States and Puerto Rico, as well as numerous international locations.
The recall is being conducted because there are confirmed reports of a component coming loose inside the CT enclosure and damaging the system. The source text does not specify the exact nature of the damage or any resulting patient injuries.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the defect in the affected systems.
The recalled product
- Product
- Symbia T and Symbia T2 computer tomography systems. These systems are used to perform SPECT, CT, and SPECT + CT scans and imaging studies.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Hazard
- Affected units
- 295
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)
- 1) Symbia T
- Part Number: 10275007
- Serial Numbers: 1055
- 1057
- 1058
- 1060
- 1061
- 1062
- 1063
- 1064
- 1065
- 1066
- 1067
- 1068
- 1069
- 1070
- 1071
- 1072
- 1073
- 1074
Distribution
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