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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81821

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 30, 2018
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

1 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 1

Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

Z-0707-2019
Recall number
Z-0707-2019
Initiated
November 30, 2018
Classification
Class II
Status
Terminated
Quantity
171

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Improper design or specifications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Improper design or specifications.

Code information

Material Number: 10532746 - Serial #'s: 94401, 94405, 94406, 94408, 94409, 94413, 94414, 94415, 94420, 94421, 94422, 94423, 94424, 94425, 94426, 94427, 94429, 94430, 94431, 94432, 94433, 94434, 94435, 94436, 94438, 94440, 94441, 94442, 94443, 94444, 94445, 94447, 94448, 94451, 94452, 94457, 94459, 94460, 94461, 94462, 94463, 94464, 94466, 94467, 94473, 94476, 94477, 94480, 94481, 94482, 94483, 94484, 94485, 94487, 94491, 94492, 94493, 94495, 94496, 94497, 94498, 94499, 94500, 94502, 94504, 94505, 94506, 94508, 94510, 94512, 94513, 94516, 94517, 94518, 94519, 94520, 94521, 94522, 94525, 94530, 94531, 94532, 94533, 94534, 94537, 94538, 94540, 94541, 94542, 94543, 94547, 94549, 94550, 94551, 94555, 94556, 94558, 94559, 94560, 94562, 94563, 94565, 94566, 94567, 94569, 94574, 94576, 94580, and 94590 Material Number: 10532748 - Serial #'s: 94402, 94407, 94410, 94412, 94416, 94417, 94418, 94419, 94428, 94446, 94449, 94450, 94453, 94454, 94455, 94456, 94465, 94470, 94471, 94472, 94475, 94478, 94479, 94486, 94488, 94489, 94490, 94494, 94501, 94503, 94507, 94524, 94527, 94528, 94536, 94539, 94544, 94546, 94548, 94552, 94554, 94557, 94561, 94575, 94585, 94587, and 94593

Distribution pattern

Worldwide Distribution - US Nationwide in the states of AZ, CA, CO, DE, FL, GA, ID, IL, IN, KY, LA, MD, ME, MN, NJ, NM, NV, NY, OH, OK, PA, TN, TX, and VA and the countries of Argentina, Australia, Bahrain, Belarus, Belgium, Brazil, Chile, China, Colombia, France, Germany, India, Iran, Ireland, Italy, Japan, Lebanon, Mexico, Netherlands, New Zealand, Philippines, South Africa, Spain, Sri Lanka, Taiwan, Turkey, and United Kingdom