FDA Device recall Z-0868-2022
MODEL: X-RAY TV SYSTEM SONIALVISION G4
- FDA Device
- Class II
- ongoing
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of MODEL: X-RAY TV SYSTEM SONIALVISION G4 by Shimadzu Medical Systems, citing it was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting crit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0868-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-10 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Shimadzu Medical Systems |
| Distribution | AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WV |
Product
MODEL: X-RAY TV SYSTEM SONIALVISION G4
Reason
It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
Identifiers
| code_info | Model: SonialVision G4 Generator Number: D150-40 Serial Numbers: 41C35166C003 41C3536B4001 41C351683006 41C3516B3…Model: SonialVision G4 Generator Number: D150-40 Serial Numbers: 41C35166C003 41C3536B4001 41C351683006 41C3516B3001 41C35169C002 41C351699002 41C351699001 41C3517AA001 41C35169B002 41C351671001 41C3516A3001 41C351661002 41C351671007 41C351683003 41C351671005 41C35179B004 41C351674001 41C35168B002 41C3517AA002 41C351685004 41C35165B002 41C3535A5001 41C353597001 41C35359C001 41C351674004 41C351685003 41C35164C001 41C351641001 41C351671004 41C351679001 41C3535A1001 41C3535A3001 41C351664004 41C351679006 41C351684004 41C351674002 41C3535A2002 41C351669002 41C351646002 41C35164A001 41C35359C002 41C351692001 41C35168B001 41C351653004 41C351664002 41C351673004 41C351663002 41C35164B001 41C351683001 41C351683002 41C351799001 41C351686002 41C351646001 41C351679005 41C351693003 41C351665002 41C35179A001 41C35165A003 41C35168A003 41C35179B005 41C35179B003 41C351671006 41C351689001 41C351799002 41C351641002 41C351671002 41C35167 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0868-2022%22
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