Welch Allyn, Inc. 901029 (REF VS100)Recalls & reported problems
Welch Allyn, Inc. · VS100 UDI BASE UNIT · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00732094214154), received between May 31, 2023 and Aug 18, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (9 reports).
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Recalls naming this device
- Feb 18, 2026Class IIOpen, Classified
Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in susceptible individuals.
Z-1573-2026 · Root cause: Device Design · Recall details · FDA record ↗
Most reported problems
Device problems
- Material Split, Cut or Torn9
- Material Frayed2
- Sparking2
- Explosion1
- Fire1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 18, 2026Material Split, Cut or Torn
Baxter received a report stating that a VS100 Spot Vision Screener had a damaged power cord, it appeared to be peeling. This occurred before use. There was no patient injury or death reported with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50291764 ↗MalfunctionJul 17, 2025Fire; Explosion; Fire; Explosion
CUSTOMER REPORTED THE BATTERY HAD EXPLODED SEVERAL TIMES AND THE DEVICE HAD CAUGHT ON FIRE. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22529989 ↗MalfunctionJul 2, 2025Sparking; Material Split, Cut or Torn; Sparking; Material Split, Cut or Torn
CUSTOMER REPORTED POWER SUPPLY FOR THIS DEVICE HAD EXPOSED WIRING ON THE CORNER THAT WAS GOING FROM THE BANK TO THE DEVICE AND WAS SPARKING. THERE WAS NO INJURY REPORTED. THIS INCIDENT WAS CAPTURED UNDER BAXTER COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22385401 ↗MalfunctionJun 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED PHYSICAL DAMAGE WITH EXPOSED COPPER WIRINGS. THERE WAS NO INJURY REPORTED. THIS INCIDENT WAS CAPTURED UNDER BAXTER COMPLAINT REF #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289205 ↗MalfunctionMay 12, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED POWER CORD IS FRAYED AND SOME WIRES ARE GETTING EXPOSED. THERE WAS NO INJURY REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002479 ↗MalfunctionApr 3, 2025Sparking; Material Split, Cut or Torn; Sparking; Material Split, Cut or Torn
CUSTOMER REPORTED PHYSICAL DAMAGE. WIRING ON THE POWER SUPPLY WAS EXPOSED BETWEEN THE ADAPTOR BOX AND THE PLUG INTO THE DEVICE AND WAS SPARKING. THERE WAS NO INJURY REPORTED. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21761326 ↗MalfunctionMar 28, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED POWER CORD HAS FRAYED, EXPOSED WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21717684 ↗MalfunctionFeb 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
CUSTOMER REPORTED DEVICE WILL NOT HOLD CHARGE BECAUSE THE POWER CORD IS BROKEN AND HAS FRAYED WIRES. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21355114 ↗MalfunctionJan 23, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
THE BAXTER TECHNICIAN FOUND EXPOSED WIRES ON THE POWER SUPPLY DURING VISUAL INSPECTION. THIS WAS A SECONDARY FINDING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21216925 ↗MalfunctionSep 30, 2024Material Frayed; Material Split, Cut or Torn; Material Frayed; Material Split, Cut or Torn
THE CUSTOMER REPORTED THAT THE VS100 POWER CORD WAS FRAYED. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT # (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20333363 ↗MalfunctionMay 31, 2023Material Frayed; Material Frayed
THE CUSTOMER REPORTED THE VS100 WOULD NOT HOLD A CHARGE WHEN UNPLUGGED. THE DEVICE WAS RETURNED FOR BENCH REPAIR WHERE THE TECHNICIAN DETERMINED THAT THE POWER CORD WAS FRAYED WITH EXPOSED WIRES. THIS INCIDENT WAS CAPTURED UNDER HILLROM COMPLAINT REF (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17032078 ↗
Other Refractometer, ophthalmic devices
- Welch Allyn, Inc. 901122Welch Allyn, Inc. · Refractometer, ophthalmic1 recall0 reports
- Welch Allyn, Inc. 901122Welch Allyn, Inc. · Refractometer, ophthalmic1 recall0 reports
- Welch Allyn, Inc. 901029Welch Allyn, Inc. · Refractometer, ophthalmic18 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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