Z-1812-2020Class II
H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM...
Mortara Instrument, Inc. / initiated 2020-03-18 / Terminated / root cause: design
WELCH ALLYN, INC/MORTARA began a recall of H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT... 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-1812-2020
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Mortara Instrument, Inc.
- Product
- H12+ and patient cable for the H12+ Holter Recorders with the following device name: PAT CBL 10WIRE LEADFORM AHA SNAP, PAT CBL 10WIRE LEADFORM IEC SNAP, PAT CBL 10WIRE LEADFORM XL AHA SNAP, PAT CBL 10WIRE LEADFORM XL IEC SNAP. The 24-hour H12+ recorder uses a single AA alkaline battery to provide continuous 12-lead data recorded over a 24-hour period and a removable 24-hour compact flash (CF) card for data storage.
- 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: H12PLUS-XXX-XXXXX, 9293-017-50, 9293-017-51, 9293-026-50, 9293-026-51.
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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