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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85161

4 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
February 18, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Siemens Medical Solutions USA, Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

4 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 4

ARTISTE MV System Model #8139789 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

Z-1677-2020
Recall number
Z-1677-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Quantity
1012

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

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Reason for recall

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

Code information

Serial Numbers 5350, 5410, 5419, 5481, 5500, 5488, 5532, 5540, 5548, 5572, 5590, 5601, 5630, 5640, 5657, 5699, 5707, 5737, 5743, 5748, 5755, 5784, 5823, 5843, 5844, 5851, 5899, 5833, 5894, 5830

Distribution pattern

Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming

device · product 2 of 4

MEVATRON M2/Primus Mid-Energy Model #01940035, MEVATRON PRIMART #05500371, MEVATRON KD-2 #08515520, MEVATRON KD2 #01940753, MEVATRON M-2 6740 #09401506, MEVATRON MD-2 #09401654, MEVATRON MDX-2 #09401746 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

Z-1678-2020
Recall number
Z-1678-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Quantity
1012

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

Code information

Serial Numbers 2507, 2516, 2596, 2689, 2818, 2962, 3013, 3103, 3089, 3136, 2855, 3296, 3397, 3591, 3629, 3639, 3644, 3702, 3873, 3939, 4018, 3986, 70-4146, 70-4347, 70-4363, 5092, 5114, 5523, 70-4287, 2045, 2067, 2125

Distribution pattern

Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming

device · product 3 of 4

ONCOR Avante Garde #5863472, ONCOR Expression #7360717, ONCOR Impression #5857920, ONCOR Impression Plus #5857912 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

Z-1679-2020
Recall number
Z-1679-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Quantity
1012

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

Code information

Serial Numbers 3905, 70-4077, 4082, 70-4283, 70-4368, 5177, 3922, 5120, 5170, 5179, 5205, 5226, 5245, 5282, 5300, 5343, 5385, 5391, 5506, 5665, 4078, 70-4143, 70-4235, 70-4296, 70-4344, 5154, 5281, 5417, 3755, 3761, 3802, 3801, 3901, 3981, 4072, 70-4174, 70-4354, 70-4378, 5087, 5088, 5096, 5095, 5098, 5118, 5148, 5396, 5157, 5821

Distribution pattern

Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming

device · product 4 of 4

PRIMUS HI #04504200 with Digital LINAC Systems Control Console Software Versions 6, 7, 9, 13

Z-1680-2020
Recall number
Z-1680-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Quantity
230,001

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential safety issue with the dose monitoring system safety interlocks which could result in a 10-20% overdose of radiation therapy.

Code information

Serial Numbers 3025, 3049, 3241, 3267, 3305, 3422, 3479, 3515, 3519, 3547, 3565, 3602, 3731, 3751, 3832, 3667, 3924, 3949, 4036, 70-4185, 5153, 3361, 3979, 3657, 3679

Distribution pattern

Worldwide distribution. US consignees in the following states: Alabama, California, Delaware, Florida, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Wisconsin, West Virginia, Wyoming