Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84441

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

Open FDA event record

Event summary

Timeline bucket
November 15, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medtronic Navigation, Inc.-Littleton

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

O-arm" O2 Imaging System, Product Number/CFN: BI-700-02000

Z-0767-2020
Recall number
Z-0767-2020
Initiated
November 15, 2019
Classification
Class II
Status
Terminated
Quantity
90

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.

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

Due to a manufacturing issue affecting particular O-arm" O2 Imaging Systems, Medtronic has determined that the gantry tractor motor drive belt may loosen over an extended number of uses at a higher frequency in these systems. If the belt loosens, it may result in rotation of 3D images about the gantry isocenter. While the 3D image is anatomically accurate within the image itself and may be used to confirm therapy, its electronic registered location may be rotated relative to the actual physical position of the patient.

Code information

SN: C2155 C2180 C2193 C2203 C2213 C2223 C2233 C2243 C2257 C2267 C2157 C2181 C2194 C2204 C2214 C2224 C2234 C2247 C2258 C2268 C2165 C2182 C2195 C2205 C2215 C2225 C2235 C2248 C2259 C2166 C2183 C2196 C2206 C2216 C2226 C2236 C2250 C2260 C2167 C2185 C2197 C2207 C2217 C2227 C2237 C2251 C2261 C2169 C2186 C2198 C2208 C2218 C2228 C2238 C2252 C2262 C2172 C2187 C2199 C2209 C2219 C2229 C2239 C2253 C2263 C2176 C2189 C2200 C2210 C2220 C2230 C2240 C2254 C2264 C2177 C2190 C2201 C2211 C2221 C2231 C2241 C2255 C2265 C2178 C2192 C2202 C2212 C2222 C2232 C2242 C2256 C2266 UDIs: 00763000074104, 00763000132378, 00763000074128, 00763000134488 00763000081003, 00763000074067, 00763000168605, 00763000074135, 00763000134518, 00763000081041, 00763000135829, 00763000081102, 00763000074050, 00763000074098, 00763000135836

Distribution pattern

US: AR CA CO CT FL ID IL IN KS KY MI MN MO NC ND NE NY OH OR PA SC SD TX VA WA WI WV OUS: AUSTRALIA CANADA CHINA FRANCE GERMANY INDIA ITALY JAPAN LEBANON NETHERLANDS ROMANIA SAUDI ARABIA SPAIN SWEDEN SWITZERLAND UNITED KINGDOM

Field note

Send feedback

We'll only use this to respond to your feedback.