Recall Z-1930-2013 ยท LPP Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Radiometer America Inc
TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Brnshj, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
| Date | Aug 8, 2013 (initiated Nov 27, 2012) |
| Status | Terminated |
| Reason | RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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, SC, SD, TN, TX, TX, UT, VA, VT, WA, WI, WV & WY; and country of: Canada. |
| FDA record | Open on fda.gov |