| | Class 2 Device Recall Vscan Extend |  |
| Date Initiated by Firm | May 21, 2019 |
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| Create Date | June 18, 2019 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1839-2019 |
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| Recall Event ID |
82938 |
| 510(K)Number | K161588 |
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| Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
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| Product | LVivo EF app on Vscan Extend. Sold under the following product names:
a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN;
b .Vscan Extend Dual USB, Model Number H41212RK;
c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL;
d. Vscan Extend Sector DICOM, Model Number H41212ZD;
e. Vscan Extend Sector USB, Model Number H41212RR;
f. Vscan Extend Sector Wi-Fi, Model Number H41212ZC
Product Usage: Vscan Extend is a general- purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It s pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, and triage. |
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| Code Information |
a. Model Number H41212ZA, Serial Number (UDI): VH162494DA (01008406821216511118060021VH162494DA), VH162530R2 (01008406821216511118060021VH162530R2), VH160454PQ (01008406821216511118040021VH160454PQ), VH161212Z9 (01008406821216511118040021VH161212Z9), VH162305WM (Not Available), VH162300UE (Not Available), VH163166GF (Not Available), VH163170QD (Not Available), VH162011PE (01008406821216511118040021VH162011PE), VH163454AQ (01008406821216511118110021VH163454AQ), VH161912X9 (01008406821216511118040021VH161912X9), VH163489ED (01008406821216511118110021VH163489ED), VH160832WB (01008406821216511118040021VH160832WB), VH162896FQ (01008406821216511118100021VH162896FQ), VH163307IQ (Not Available), VH160748G4 (01008406821216511118040021VH160748G4), VH163100A6 (Not Available), VH162900GC (Not Available), VH163879G6 (Not Available), VH163278ZM (Not Available), VH162142TV (Not Available), VH163485KC (Not Available), VH163031AZ (Not Available), VH163175AT (Not Available), VH162126EN (Not Available), VH163659A8 (Not Available), VH1633048M (Not Available), VH163350EC (Not Available), VH163326UE (Not Available), VH163770L1 (Not Available), VH163784LD (Not Available), VH163036JA (Not Available), VH161216M7 (Not Available), VH1620432N (01008406821216511118040021VH1620432N), H41212RN, Serial Number (UDI): VH160254IY (Not Available), VH1607044U (Not Available), VH160176N2 (Not Available), VH1600406Z (Not Available), VH160053C5 (01008406821216511117020121VH160053C5), VH160485GP (Not Available), VH160181WQ (Not Available), VH161330TM (Not Available), VH160164PH (Not Available), VH16055084 (Not Available); b .Model Number H41212RK, Serial Number (UDI): VH160462WV (Not Available), VH16092049 (Not Available); c. Model Numbers H41212YZ, Serial Number (UDI): VH163439U9 (Not Available), VH163527ZC (Not Available), VH163066UJ (Not Available), VH163340NW (Not Available), VH163458CU (Not Available), VH163502LY (Not Available), VH163511T8 (Not Available), VH1636016Y (Not Available), VH163755YI (Not Available), VH163691TX (Not Available), VH1637399H (Not Available), VH163746S1 (Not Available), VH163764NN (Not Available), VH163763GE (Not Available), VH163759LP (Not Available), VH163765G2 (Not Available), VH163116N7 (Not Available), VH163044T8 (Not Available), VH162988WW (Not Available), VH163374LA (Not Available), VH163398MZ (Not Available), VH163428UW (Not Available), VH163415KB (Not Available), VH163446Z5 (Not Available), VH1634671E (Not Available), VH1636924B (Not Available), VH163744SF (Not Available), VH1637439Z (Not Available), VH1637388B (Not Available), VH163747I4 (Not Available), VH163741W3 (Not Available), VH163761IM (Not Available), VH16374052 (Not Available), VH163762TT (Not Available), VH163756TX (Not Available), VH1637451Y (Not Available), VH163766TJ (Not Available), VH163461K7 (Not Available), VH1634367P (Not Available), VH163383YB (Not Available), VH163493AE (Not Available), VH163477CV (Not Available), VH163445UT (Not Available), VH163676PS (Not Available), VH163671M1 (Not Available), VH1636685E (Not Available), VH163672YP (Not Available), VH1617429V (Not Available), VH163373TQ (Not Available), VH1634495A (Not Available), VH162698PH (Not Available), VH163113IV (Not Available), VH1633366P (Not Available), VH163002F8 (Not Available), VH163093EU (Not Available), VH16313978 (Not Available), VH163450F7 (Not Available), VH163751QX (Not Available), VH1632313N (Not Available), VH163748WX (Not Available), VH163754PU (Not Available), VH163742K9 (Not Available), VH1631245M (Not Available), VH162779KK (Not Available), H41212RL, Serial Number (UDI): VH1600189D (Not Available), VH1606843M (Not Available), VH1604606U (Not Available); d. Model Number H41212ZD, Serial Number (UDI): VH1505638R (Not Available), VH150582C6 (Not Available), VH150663J5 (Not Available), VH150553A2 (Not Available); e. Model Number H41212RR, Serial Number (UDI): VH150282CY (Not Available); f. Model Number H41212ZC, Serial Number (UDI): VH150657SF (Not Available) |
Recalling Firm/
Manufacturer |
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
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| For Additional Information Contact |
800-437-1171 |
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Manufacturer Reason
for Recall | Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product. |
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FDA Determined
Cause 2 | Software design |
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| Action | GE Healthcare notified customers on about 05/21/2019 via "URGENT MEDICAL DEVICE CORRECTION" letter. Customers were instructed to discontinue use of the LVivo EF app until a correction is available and installed on the Vscan Extend. However Vscan Extend can continue to be used for all other existing cleared indications including all other Vscan Extend apps and measurements.
GE Healthcare will correct all affected products at no cost. When the LVivo EF app update is available through GE Marketplace, customers will receive an email notification sent to the email address they set up during the Vscan Extend device registration process.
Questions or concerns regarding the notification can be directed to GE Healthcare Service at 1-800-437-1171 or your local Service Representative. |
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| Quantity in Commerce | 119 units |
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| Distribution | Worldwide distribution - US nationwide distributed in the states of CA, FL, IL, MA , MD, MI, MN, NY, SC, TX, UT. Countries of Australia, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Korea (Republic Of), Netherlands, Romania, Sweden, Switzerland, Thailand, United Kingdom. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = IYN
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