FDAClass IISeptember 30, 2020

Discovery 670 DR recall

Discovery 670 DR Model # H3100BT

Why was Discovery 670 DR recalled?

Rotor bearing screws were found loose on detector.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Serial # DRGX56002 System ID: 4445804NM11 Serial # DRGX56005 System ID: 614CVA6702CT Serial # DRGX56004 System ID: 403343D670A Serial # DRGX56017 System ID: 110002NU06 Serial # DRGX56018 System ID: X7410502 Serial # DRGX56003 System ID: 403438NU02 Serial # DRGX56010 System ID: UC4097NU02 Serial # DRGX56008 System ID: 826251NU01 Serial # DRGX56007 System ID: H2101NUC35 Serial # DRGX56006 System ID: 083026063363718 Serial # DRGX56011 System ID: 083026281900218 Serial # DRGX56009 System ID: 083049206531619 Serial # DRGX56021 System ID: 083026603411518 Serial # DRGX56019 System ID: A220806209 Serial # DRGX56012 System ID: STD01300 Serial # DRGX56014 Not Available Serial # DRGX56016 System ID: GEE34069 Serial # DRGX56020 System ID: DEL26498 Serial # DRGX56022 System ID: DE6588153 Serial # DRGX56015 System ID: 0853260202

Product
Discovery 670 DR Model # H3100BT
Recalling firm
GE Healthcare, LLC
Quantity
20 units
Distribution
USA : AR CT FL GA IL KS KY LA MA MD MI MN MO NE NJ NV NY OH OK RI SC TN TX VA VT WA WI OUS: ARGENTINA AUSTRIA BELGIUM BRAZIL Canada CHINA FRANCE GERMANY GREECE INDIA ISRAEL ITALY JAPAN Korea (Republic of) NETHERLANDS NORWAY PANAMA POLAND PORTUGAL Russia SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM VIETNAM
Recall date
September 30, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls