Health CanadaType II
REVOLUTION CT (2021-10-11)
Published: October 11, 2021Recall ID: RA-76709Category: generalCountry: Canada
Product Description & Identification
REVOLUTION CT (2021-10-11)
Additional Source Details
| Field | Value |
|---|---|
| Panels › 1 › Text | <b>Issue:</b> Medical Devices<BR/><b>Audience:</b> General Public, Healthcare Professionals, Hospitals<BR/><b>Category:</b> Medical Device<BR/><b>Alert type:</b> Medical Device Recall<BR/><b>Department:</b> Health Canada<BR/><b>Hazard classification:</b> Type II<BR/> |
| Panels › 1 › Title | Summary |
| Panels › 1 › Panel Name | basic_details |
| Panels › 2 › Text | Affected Products<BR/><p> A. REVOLUTION CT - MAIN UNIT<br /> B. REVOLUTION CT ES<br /> C. REVOLUTION APEX</p> |
| Panels › 2 › Title | Introduction |
| Panels › 2 › Panel Name | intro_text |
| Panels › 3 › Text | There is a potential for the accumulated dose to be incorrectly displayed in certain situations. During an interventional exam using the Smartstep option, if the table height is adjusted after the exam starts, the Smartstep display will show a value that is higher than the actual dose delivered. |
| Panels › 3 › Title | Reason |
| Panels › 3 › Panel Name | cms_reason_reason_recall |
| Panels › 4 › Text | <b>Brand name:</b> A. REVOLUTION CT - MAIN UNIT<br/><b>Lot or serial number:</b> 00000440051CN1<br /> 00000441839CN8<br /> 00000443342CN1<br /> 00000445060CN7<br /> REVVX1600054CN<br /> REVVX1700084CN<br /> REVVX1900034CN<br /> REVVX1900098CN<BR/><b>Model or catalog number:</b> 5590000<br /> 5590000-6<BR/><b>Companies:</b><br/><dl><dt>Manufacturer</dt><dd>GE Medical Systems LLC</dd><dd>3200 North Grandview Blvd</dd><dd>Waukesha</dd><dd>53188</dd><dd>UNITED STATES</dd></dl> |
| Panels › 4 › Title | A. REVOLUTION CT - MAIN UNIT |
| Panels › 4 › Panel Name | product_1 |
| Panels › 5 › Text | <b>Brand name:</b> B. REVOLUTION CT ES<br/><b>Lot or serial number:</b> REVV81900029CN<br /> REVV81900035CN<BR/><b>Model or catalog number:</b> 5590000-15<BR/><b>Companies:</b><br/><dl><dt>Manufacturer</dt><dd>GE Medical Systems LLC</dd><dd>3200 North Grandview Blvd</dd><dd>Waukesha</dd><dd>53188</dd><dd>UNITED STATES</dd></dl> |
| Panels › 5 › Title | B. REVOLUTION CT ES |
| Panels › 5 › Panel Name | product_2 |
| Panels › 6 › Text | <b>Brand name:</b> C. REVOLUTION APEX<br/><b>Lot or serial number:</b> REV2A2000017CN<br /> REV2A2000029CN<BR/><b>Model or catalog number:</b> 840682146616<BR/><b>Companies:</b><br/><dl><dt>Manufacturer</dt><dd>GE Medical Systems LLC</dd><dd>3200 North Grandview Blvd</dd><dd>Waukesha</dd><dd>53188</dd><dd>UNITED STATES</dd></dl> |
| Panels › 6 › Title | C. REVOLUTION APEX |
| Panels › 6 › Panel Name | product_3 |
| Panels › 7 › Text | <b>Identification number:</b> RA-76709<BR/> |
| Panels › 7 › Title | Identification number |
| Panels › 7 › Panel Name | id_numbers |
| Recall Id | RA-76709 |
| Start date | 1633910400 |
| Date published | 1634860800 |