Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Serial #: 85170, 85175, 85346, 85362, 85082, 85083, 85450, 85479, 85035, 85476, 85358,8 4184, 85191, 85377,8 5387, 85903, 85487, 85060, 85415, 85857, 85858,85856,85339,85410,85381,85189,85860, 85447, 85448, 85895,85896, 85401,85368, 85307, 85308, 85309, 85310, 85396, 85399, 85400, 85872, 85873, 85874, 85875, 85876, 85899, 85341, 85421, 85422, 85485, 85332, 85409, 85870, 85850,85851,85360,85143, 85395, 85359,85879, 85108,85225, 85234, 85235, 85194,85195,85436, 85437,85334 85239, 85322, 85462, 85355, 85356, 85364, 85365, 85433, 85910,85881,85149, 85354, 85366, 85199, 85364,85040,85474, 85282,85054,85382,85049, 85085,85338,85865, 85147,85148, 85115, 85866, 85867,85073, 85440,85319,85342, 85343, 85438, 85426, 85062, 85067, 85353, 85918,85145,85441, 85330,85909,85407, 85079, 85080, 85456, 85050, 85908, 85176, 85172, 85335, 85484, 85424,85859, 85177,85045,85047,85897,85389, 85051, 85053, 85036, 85244,85248,85340, 85884,85886,85118, 85329, 85852,85418,85390, 85391,85361,85146, 85090, 85091, 85458,85092, 85099, 85880, 85883,85394,85403,85404, 85465, 85086, 85081,85414, 85416,85393, 85887, 85420, 85376, 85427, 85380, 85041,85042, 85891, 85186,85477, 85020, 85021,85325, 85350,85023,85024,85066, 85057, 85178,85900, 85871, 85435, 85345, 85352, 85481,85482, 85167,85168, 85470, 85453, 85442, 85321, 8585893,85468,85469, 85388,85157, 85232, 85187, 85439, 85848, 85223, 85016, 85017,85375, 85383,85384,85385, 85373, 85374, 85281, 85344, 85905,85904, 85906,85144,85326, 85327, 85473,85467, 85134, 85133, 85238, 85370, 85911, 85357
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Siemens Medical Solutions USA, Inc
Reason for Recall:
Siemens' conducting a recall due to a potential issue when using the measurement package of the VA10 version of syngo Dynamics.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Siemens Syngo Dynamics-a Picture Archiving and Communication System (PACS) Model Numbers: 10091805, 10091807, 10091637, 10091673 intended for acceptance, transfer, display, storage, archive acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Not intended for reading of mammography images.

Product Codes/Lot Numbers:

Serial #: 85170, 85175, 85346, 85362, 85082, 85083, 85450, 85479, 85035, 85476, 85358,8 4184, 85191, 85377,8 5387, 85903, 85487, 85060, 85415, 85857, 85858,85856,85339,85410,85381,85189,85860, 85447, 85448, 85895,85896, 85401,85368, 85307, 85308, 85309, 85310, 85396, 85399, 85400, 85872, 85873, 85874, 85875, 85876, 85899, 85341, 85421, 85422, 85485, 85332, 85409, 85870, 85850,85851,85360,85143, 85395, 85359,85879, 85108,85225, 85234, 85235, 85194,85195,85436, 85437,85334 85239, 85322, 85462, 85355, 85356, 85364, 85365, 85433, 85910,85881,85149, 85354, 85366, 85199, 85364,85040,85474, 85282,85054,85382,85049, 85085,85338,85865, 85147,85148, 85115, 85866, 85867,85073, 85440,85319,85342, 85343, 85438, 85426, 85062, 85067, 85353, 85918,85145,85441, 85330,85909,85407, 85079, 85080, 85456, 85050, 85908, 85176, 85172, 85335, 85484, 85424,85859, 85177,85045,85047,85897,85389, 85051, 85053, 85036, 85244,85248,85340, 85884,85886,85118, 85329, 85852,85418,85390, 85391,85361,85146, 85090, 85091, 85458,85092, 85099, 85880, 85883,85394,85403,85404, 85465, 85086, 85081,85414, 85416,85393, 85887, 85420, 85376, 85427, 85380, 85041,85042, 85891, 85186,85477, 85020, 85021,85325, 85350,85023,85024,85066, 85057, 85178,85900, 85871, 85435, 85345, 85352, 85481,85482, 85167,85168, 85470, 85453, 85442, 85321, 8585893,85468,85469, 85388,85157, 85232, 85187, 85439, 85848, 85223, 85016, 85017,85375, 85383,85384,85385, 85373, 85374, 85281, 85344, 85905,85904, 85906,85144,85326, 85327, 85473,85467, 85134, 85133, 85238, 85370, 85911, 85357

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1183-2016

Related Recalls

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

Mar 9, 2026 Other Medical Devices View Details β†’
Class I - Dangerous

During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

Mar 9, 2026 Other Medical Devices View Details β†’

ARTIS Pheno VE30A and VE40A, Model 10849000

Siemens Medical Solutions USA

Class I - Dangerous

During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the angular change of patient diameter caused by rotational acquisition. This may result in unintentional low-dose radiation exposure to a patient.

Mar 12, 2026 Other Medical Devices View Details β†’