Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA
Medical device recall Z-1168-2013. Published in FDA’s Enforcement Report on May 1, 2013.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 1, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 40 states named in where it went
- 556 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE Healthcare has recently become aware of an incident which caused a patient injury during an unload following an exam on a Ventri scanner. During a patient unload following a scan, the patients fingers may be pinched between the moving cradle edge and the stationary base of the table while the table is moving outward automatically.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
556, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial # 19069 19082 19065 19015 19057 19008 19005 19075 19064 19066 19078 19034 19061 19041 19081 19036 19058 16006 19151 19091 16013 19049 19073 19059 19016 0000000ME11041 19027 19062 19012 19030 16001 19097 19072 19035 19043 16014 19032…
Every code shown here, 1,998 characters
Serial # 19069 19082 19065 19015 19057 19008 19005 19075 19064 19066 19078 19034 19061 19041 19081 19036 19058 16006 19151 19091 16013 19049 19073 19059 19016 0000000ME11041 19027 19062 19012 19030 16001 19097 19072 19035 19043 16014 19032 19020 19022 16004 16009 19053 16008 19093 19004 19029 19076 19050 16002 19019 19006 19038 16005 00000000VEN002 11021 0000000 VEN005 11039 11019 11001 11027 11008 11031 11028 11046 11038 11015 11045 11044 11043 11025 11018 11030 11033 11022 11026 11002 11003 11029 11032 11009 11020 11007 00000000VEN003 11010 11037 11013 11005 11041 11040 11006 00000000VEN004 11138 11220 11093 11294 11801 11228 11251 11253 11248 11209 11247 11193 11262 11214 11261 11054 11189 11092 11244 11260 11087 11255 11359 11231 11059 11237 11303 11212 11300 11417 11397 11391 11389 11232 11263 11210 11213 11208 11023 11290 11215 11091 11252 11245 11072 11219 11394 11205 11202 11225 11049 11131 11156 11242 11292 11243 11291 11102 11108 11298 11319 11250 11254 11384 11258 11257 11035 11114 000E3GT08064A6 0000E3GT09163A 0000E3GT08038A 0000INDNVC0041 0000E3GT10189A 0000E3GT09136A 11075 11430 11137 11154 11233 11052 11322 11301 11286 11078 11327 11125 11152 11387 11337 11396 11288 11147 11395 11427 11328 11450 11128 11471 11165 11424 11448 11421 11332 11203 11468 11363 11069 11127 11284 11124 11229 11297 11190 11204 11306 11061 11161 11151 11441 11067 11336 11435 11077 11191 11497 11206 11192 11211 11085 11325 11222 11392 11169 11347 11166 11050 11470 11464 11280 11469 11376 11310 11119 11501 11076 11086 11140 11366 11178 11495 11383 11352 11345 11358 11223 11183 11422 11004 11307 11107 11074 11293 11276 11270 11218 11142 11145 11060 11170 11188 11431 11088 11275 11462 11465 11117 11179 11414 11150 11149 11455 11089 11374 11056 11453 11017 11279 11146 11324 11320 11360 11371 11385 11467 11273 11266 11230 11353 11409 11349 11101 11148 11315 11410 11461 11228 11443 11123 11090 11082 11438 11287 11454 11491 11065 11080 11084 11269 11299 11130 11043 11278 11053 11070…
FDA’s list runs to 3,433 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US, including the states of AL, AZ, AR, CA, CO, CT, DE, DC, FL, IL, IN, IA, KY, LA, ME, MD, MA, MI, ,N,MS, MO, NE, NV, NH, NJ, NM, NY,NC, OH, OK,OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WI and the countries of TAIWAN, TURKEY, SINGAPORE, SWD EN, PORTUGAL, POLAND, NEW ZEALAND, NORWAY, NETHERLANDS, MALAYSIA, MEXICO, SOUTH KOREA, JAPAN, ITALY, INDIA, ISRAEL GREAT BRITAIN, FRANCE, DENMARK, GERMANY, SWITZERLAND, CANADA, BRAZIL BELGIUM, AUSTRALIA, and ARGENTINA.
The states and territories these words name
40 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Iowa
- Illinois
- Indiana
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Missouri
- Mississippi
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 9, 2013.
- FDA classified it on Apr 24, 2013.
- FDA’s Enforcement Report published it on May 1, 2013.
- FDA terminated it on Aug 6, 2013.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,433 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.