TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiomet
FDA device recall Z-1930-2013 · posted 2013-08-08 · Terminated
Recall details
- Recalling firm
- Radiometer America Inc
- Reason for recall
- RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B.
- Action taken
- On 11/30/2012 the firm sent an "Urgent Field Safety Notice" to their customers. The notification explained the issue and provided recommended actions. Customers may contact 1-800-736-0600 option 4 with questions.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LPP
- Quantity affected
- 5,874 units
- Distribution
- Worldwide distribution: US (nationwide) 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, OR, PA, RI,
- Date initiated
- 2012-11-27
- Date posted
- 2013-08-08
- Date terminated
- 2014-06-16
- Location
- Westlake, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TCM40 MONITORING SYSTEM (K043003) | Radiometer Medical Aps | 2005-03-01 |
| TCM400 (K001866) | Radiometer Medical A/S | 2000-12-07 |