GE Vscan Extend, being sold as "Vscan Extend Dual USB"
FDA Device Recall #Z-0520-2022 — Class II — November 4, 2021
Recall Summary
| Recall Number | Z-0520-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 4, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | GE Healthcare, LLC |
| Location | Waukesha, WI |
| Product Type | Devices |
| Quantity | 12,526 total reported units (77 units of this model) |
Product Description
GE Vscan Extend, being sold as "Vscan Extend Dual USB"
Reason for Recall
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
Distribution Pattern
Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, PR, and DC. International: Albania, Australia, Austria, Bahrain, Bangladesh, Belgium, Bosnia, Brazil, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dubai, Ecuador, El Salvador, Estonia, Fiji, Finland, France, Germany, Greece, Haiti, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Moldova, Morocco, Myanmar, Netherlands, New Zealand, Norway, Papua New Guinea, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, Somalia, South Africa, Spain, Sweden, Switzerland, Thailand, Togo, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, United Kingdom, Vietnam, and Western Sahara.
Lot / Code Information
Information reads "Serial Number (UDI, Model Nubmer)". VH1602482A (01008406821216511117040721VH1602482A, H41212RK), VH160398U2 (01008406821216511117040021VH160398U2, H41212RK), VH160910MS (01008406821216511117090021VH160910MS, H41212RK), VH160692PU (01008406821216511117060021VH160692PU, H41212RK), VH16072033 (01008406821216511117060021VH16072033, H41212RK), VH164639E1 (01008406821216511119060021VH164639E1, H41212YY), VH165023E4 (01008406821216511119090021VH165023E4, H41212YY), VH26557563 (01008406821216511121071221VH26557563, H41212YY), VH265583RM (01008406821216511121070921VH265583RM, H41212YY), VH2656017N (01008406821216511121070821VH2656017N, H41212YY), VH265638Q4 (01008406821216511121070921VH265638Q4, H41212YY), VH26564046 (01008406821216511121070921VH26564046, H41212YY), VH265645Q7 (01008406821216511121070821VH265645Q7, H41212YY), VH265647U2 (01008406821216511121070921VH265647U2, H41212YY), VH265836ZG (01008406821216511121071221VH265836ZG, H41212YY), VH265838JV (01008406821216511121071221VH265838JV, H41212YY), VH265842CE (01008406821216511121071221VH265842CE, H41212YY), VH265844SA (01008406821216511121070921VH265844SA, H41212YY), VH265845WV (01008406821216511121071221VH265845WV, H41212YY), VH265849MM (01008406821216511121070921VH265849MM, H41212YY), VH265851HS (01008406821216511121071221VH265851HS, H41212YY), VH26585212 (01008406821216511121070921VH26585212, H41212YY), VH265857ZW (01008406821216511121070921VH265857ZW, H41212YY), VH265858LY (01008406821216511121071221VH265858LY, H41212YY), VH265864P5 (01008406821216511121070921VH265864P5, H41212YY), VH1632681A (01008406821216511118100021VH1632681A, H41212YY), VH160462WV (01008406821216511117040021VH160462WV, H41212RK), VH160549FR (01008406821216511117060021VH160549FR, H41212RK), VH16055357 (01008406821216511117060021VH16055357, H41212RK), VH160673KV (01008406821216511117060021VH160673KV, H41212RK), VH160674YQ (01008406821216511117060021VH160674YQ, H41212RK), VH160717US (01008406821216511117060021VH160717US, H41212RK), VH160724UV (01008406821216511117110021VH160724UV, H41212RK), VH160844BL (01008406821216511117110021VH160844BL, H41212RK), VH160851T5 (01008406821216511117110021VH160851T5, H41212RK), VH160879LS (01008406821216511117090021VH160879LS, H41212RK), VH16090735 (01008406821216511117090021VH16090735, H41212RK), VH160911AW (01008406821216511117090021VH160911AW, H41212RK), VH16092049 (01008406821216511117090021VH16092049, H41212RK), VH160934IF (01008406821216511117090021VH160934IF, H41212RK), VH160940WS (01008406821216511117100021VH160940WS, H41212RK), VH160984TC (01008406821216511117100021VH160984TC, H41212RK), VH161007CG (01008406821216511117100021VH161007CG, H41212RK), VH161008JP (01008406821216511117100021VH161008JP, H41212RK), VH161028CS (01008406821216511117100021VH161028CS, H41212RK), VH1610527V (01008406821216511117100021VH1610527V, H41212RK), VH1610803G (01008406821216511117100021VH1610803G, H41212RK), VH161086VQ (01008406821216511117100021VH161086VQ, H41212RK), VH1610908L (01008406821216511117100021VH1610908L, H41212RK), VH16109229 (01008406821216511117100021VH16109229, H41212RK), VH161231L5 (01008406821216511117110021VH161231L5, H41212RK), VH161675YG (01008406821216511118030021VH161675YG, H41212RK), VH162475JG (01008406821216511118100021VH162475JG, H41212YY), VH162998CK (01008406821216511118100021VH162998CK, H41212YY), VH1630084S (01008406821216511118100021VH1630084S, H41212YY), VH1633236I (01008406821216511118110021VH1633236I, H41212YY), VH16065514 (01008406821216511117050021VH16065514, H41212RK), VH162006EW (01008406821216511118030021VH162006EW, H41212RK), VH165572VH (01008406821216511119080021VH165572VH, H41212YY), VH2631208T (01008406821216511120081721VH2631208T, H41212YY), VH263163KT (01008406821216511120081721VH263163KT, H41212YY), VH263287F8 (01008406821216511120081721VH263287F8, H41212YY), VH262239Y9 (01008406821216511120061221VH262239Y9, H41212YY), VH262110GZ (01008406821216511120060221VH262110GZ, H41212YY), VH262109PN (01008406821216511120060221VH262109PN, H41212YY), VH260405KN (01008406821216511119120021VH260405KN, H41212YY), VH261920X9 (01008406821216511120051821VH261920X9, H41212YY), VH263156PR (01008406821216511120091521VH263156PR, H41212YY), VH262014IC (01008406821216511120060221VH262014IC, H41212YY), VH262086QK (01008406821216511120052921VH262086QK, H41212YY), VH261683Q7 (01008406821216511120052921VH261683Q7, H41212YY), VH262773P1 (01008406821216511120070621VH262773P1, H41212YY), VH265406KA (01008406821216511121051821VH265406KA, H41212YY), VH263551YR (01008406821216511120101321VH263551YR, H41212YY), VH2630353P (01008406821216511120101321VH2630353P, H41212YY), VH263549DB (01008406821216511120101321VH263549DB, H41212YY), VH1632534K (01008406821216511118100021VH1632534K, H41212YY), VH160006DB (01008406821216511116080021VH160006DB, H41212RK), VH160022AZ (01008406821216511116080021VH160022AZ, H41212RK), VH264900CN (01008406821216511121030921VH264900CN, H41212YY), VH264904KF (01008406821216511121030921VH264904KF, H41212YY), VH165707BB (01008406821216511119120021VH165707BB, H41212YY)
Other Recalls from GE Healthcare, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1566-2022 | Class II | (1) GE Centricity Universal Viewer 6.0, Model 2... | Jul 15, 2022 |
| Z-1430-2022 | Class II | SIGNA Premier magnetic resonance scanner, model... | Jun 24, 2022 |
| Z-1466-2022 | Class II | Centricity PACS Software Version 7.0 SP0.0.4.7 | Jun 14, 2022 |
| Z-1333-2022 | Class II | GE Centricity Universal Viewer Zero Footprint. ... | Jun 8, 2022 |
| Z-1511-2022 | Class II | Service manuals for the CT, PET, or NM table as... | Jun 2, 2022 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.