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Shimadzu Medical Systems Recall 89596

Description: MODEL: X-RAY TV SYSTEM SONIALVISION G4

Shimadzu Medical Systems Recall 89596 Information

StatusOngoing
Mandated?FDA Mandated
Recall NumberZ-0868-2022
Event ID89596
Event DescriptionMODEL: X-RAY TV SYSTEM SONIALVISION G4
Product TypeDevices
DistributionU.S.: 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, and WV. O.U.S.: N/A
Quantity176 systems
Recall ReasonIt 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.
Device Classification20220413
Device Code InfoModel: 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 41C351676002 41C35165A001 41C351643001 41C35165A002 41C351655001 41C351695003 41C351647001 41C35166A002 41C351693002 41C351695001 41C351664005 41C351673003 41C35166C001 41C3535AC001 41C35166A001 41C35168B003 41C35169C001 41C3517B1001 41C3518B4002 41C351653002 41C3518B4001 41C35168A004 41C351665003 41C351678002 41C351684001 41C351683005 41C351693001 41C351671003 41C35179C001 41C351677001 41C35167A001 41C35165B001 41C351676001 41C351662001 41C35168C002 41C351668002 41C351679004 41C351677002 41C35179B001 41C351684005 41C351692003 41C351653003 41C351666002 41C351682002 41C351685001 41C351677003 41C353597002 41C3517A2002 41C351661001 41C35168C005 41C35168A002 41C35169A001 41C351663001 41C351692004 41C35168C004 41C351664001 41C351681001 41C351651002 41C351684006 41C3535A2001 41C351679007 41C351799003 41C351667001 41C351678001 41C351683004 41C351681002 41C351656001 41C351655003 41C3516B3002 41C3517B3002 41C3518B5001 41C3518B5002 41C3518B7001 41C3536B7001 41C351656002 41C35166C002 41C35168C001 41C351679002 41C351651001 41C351686001 41C351692002 41C3517A2001 41C35168A001 41C35166A003 41C351665001 41C351659001 41C3535A3002 41C351653005 41C351684003 41C3517A3001 41C351685002 41C3517A3002 41C351688001 41C351666001 41C351673002 41C351793001 41C351641003 41C351682001 41C351673001 41C35169B001 41C351695002 41C351655002 41C351679003 41C35168C003 41C35179B002 41C3517B1002 41C3517B3001 41C351668001 41C351669001 41C351654002
Center Classification Date20220406
Recall Initiation Date20220110
Recalling FirmShimadzu Medical Systems
Initial Notification Letter
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