Z-1810-2020Class II
Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI...
Mortara Instrument, Inc. / initiated 2020-03-18 / Terminated / root cause: design
WELCH ALLYN, INC/MORTARA began a recall of Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex... on . FDA classified it as Class II and gives the reason as "Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1810-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Mortara Instrument, Inc.
- Product
- Lead diagnostic electrocardiograph under the following device names: ELI 10, ELI 350, ELI 150c, ELI 250c, ELI 230, ELI 280, ELI 380, R-Scribe and Connex Cardio. Product Usage: A non-invasive prescription device indicated for use to acquire, analyze, display, transmit and print electrocardiograms.
- Product code
- DPS Electrocardiograph
- Reason for recall
- Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Welch Allyn notified customers on 2/19/2020 via "Voluntary Medical Device Correction Welch Allyn Patient Cables or Lead Sets". The recall letter identified the affected product and stated the reason for the recall. The firm also requested the distributors to immediately notify accounts if the product was further distributed.
- Quantity in commerce
- 78,521 units total
- Distribution
- US nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, ON, OR, PA, PR, RI, SC, SD, TN,UT, VA, VT, WA, WI, WV and WY.
- Product codes and lots
- Model Numbers: ELI10-XXX-XXXXX, ELI350-XXX-XXXXX, ELI150C-XXX-XXXXX, ELI250C-XXX-XXXXX, ELI230-XXX-XXXXX, ELI280-XXX-XXXXX, ELI380-XYYZZ, RSCRIBE-xxx-xxxxx and CC-XXX-XXXX.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1810-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1811-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1812-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1813-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1814-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1815-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1816-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1817-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1818-2020 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1819-2020 | Class II | Terminated | Voluntary: Firm initiated |
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