Siemens Biograph Mobile PET/CT Recall for Missing Instructions
Siemens Medical Solutions is recalling six Biograph Mobile PET/CT units because mobile-specific instructions were not shipped to a limited population of systems.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for missing documentation (instructions) with no reported injuries or illnesses, which aligns with the rubric for documentation issues and packaging-only problems.
Plain-English summary
Siemens Medical Solutions USA Inc. is recalling six units of the Biograph 6 TruePoint Mobile PET/CT (Material Number 10097290). The recall was initiated because the mobile-specific instructions were not shipped to a limited population of these systems.
The affected devices are intended to be utilized by appropriately trained health care professionals to image and measure the distribution of injected positron emitting radiopharmaceuticals in humans and to produce cross-sectional images of the body. The recall number is Z-1423-2017.
The affected units were distributed worldwide, including in the United States (CA, CT, FL, GA, IL, KY, MA, MI, ND, NJ, OH, OK, OR, PA, TN, WA, WI, WY) and in Switzerland, Great Britain, and Italy. Affected serial numbers include 1010, 1015, 1034, 1044, 45503, and 45537. Health care professionals should contact Siemens Medical Solutions USA Inc. for further instructions regarding the missing documentation.
The recalled product
- Product
- Biograph 6 TruePoint, Material Number 10097290 The Biograph Mobile PET/CTs are intended to be utilized by appropriately trained health care professionals to: ¿ Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of…
- Manufacturer
- Siemens Medical Solutions USA Inc.
- Hazard
- Affected units
- 6
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 (6)
- 1010
- 1015
- 1034
- 1044
- 45503
- 45537
Distribution
Part of a larger recall action
This product is one of 4 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.
See all 4 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA Inc.
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · documentation issue
See all →- LowHeartSine Defibrillators Recalled for Missing Maintenance Supplement
FDA (Devices) · 2026-10-07
- SevereBMC Medical Luna G3 APAP Devices Recalled for Retroactive Rework Reporting
FDA (Devices) · 2026-08-26
- LowFARASTAR Cardiac Ablation Generator Recall for Missing Catheter Information
FDA (Devices) · 2026-07-29
- ModerateFARASTAR Ablation Generator EU Medical Device Recall for Labeling Discrepancy
FDA (Devices) · 2026-07-29
- LowPenner bathing spa models recalled for lacking a unique device identifier
FDA (Devices) · 2026-03-18
Similar recalls
- ModerateSiemens Biograph 6 TruePoint Scanners Recalled for Calibration Error Risk
FDA (Devices) · 2016-06-29
- ModerateSiemens Biograph 40 TruePoint PET/CT Scanner Recall for Calibration Error
FDA (Devices) · 2016-06-29
- ModerateSiemens Biograph 16 TruePoint PET/CT Scanners Recalled for Calibration Error
FDA (Devices) · 2016-06-29
- ModerateSiemens Biograph mCT-S PET/CT Scanner Recall for Calibration Error
FDA (Devices) · 2016-06-29
- ModerateSiemens Biograph TruePoint PET/CT Scanners Recalled for Calibration Error
FDA (Devices) · 2016-06-29
- ModerateSiemens Biograph mCT-S PET/CT Scanners Recalled for Calibration Error
FDA (Devices) · 2016-06-29