FDA Device recall Z-1168-2013
Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imag…
- FDA Device
- Class II
- terminated
- Published 2013-05-01
On 2013-05-01 the FDA classified a Class II recall of Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imag… by Ge Healthcare, citing 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 sc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1168-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-01-09 |
| Published | 2013-05-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | AL, AR, AZ, CA, CO, CT, DC, DE, FL, IA, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV |
Product
Ventri Discovery NM 530c, Ventri with Premium Table Discovery NM 530c, models H3000ZW & H3000SA. The system is used to perform nuclear imaging procedures.
Reason
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.
Identifiers
| code_info | Serial # 19069 19082 19065 19015 19057 19008 19005 19075 19064 19066 19078 19034 19061 19041 19081 1903…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1168-2013%22
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