SonarMed Inc Recall 94302
Description: AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring.
SonarMed Inc Recall 94302 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1535-2024 |
| Event ID | 94302 |
| Event Description | AW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway monitoring. |
| Product Type | Devices |
| Distribution | _AK, AZ, CA, FL, IL, KY, MD, MO, NC, NJ, NY, OH, OR, PA, SC, TN, TX, VA, & WA_ |
| Quantity | 145 units |
| Recall Reason | Software anomaly resulted in failure to detect a partial obstruction in 2.5 mm sensors and up to 3mm distal to the sensor. |
| Device Classification | 20240424 |
| Device Code Info | Model No. AW-M0001; GTIN: 00851334007001; Serial No. AW0572, AW0573, AW0574, AW0577, AW0578, AW0579, AW0580, AW0581, AW0584, AW0585, AW0586, AW0588, AW0591, AW0593, AW0594, AW0600, AW0606, AW0607, AW0615, AW0616, AW0624, AW0626, AW0627, AW0648, AW0650, AW0651, AW0658, AW0664, AW0672, AW0674, AW0675, AW0678, AW0680, AW0681, AW0684, AW0685, AW0701, AW0702, AW0703, AW0704, AW0705, AW0706, AW0707, AW0708, AW0709, AW0710, AW0711, AW0712, AW0718, AW0719, AW0720, AW0721, AW0722, AW0723, AW0724, AW0725, AW0726, AW0727, AW0728, AW0729, AW0730, AW0731, AW0732, AW0733, AW0734, AW0735, AW0736, AW0737, AW0738, AW0739, AW0740, AW0741, AW0742, AW0743, AW0744, AW0745, AW0746, AW0747, AW0748, AW0749, AW0763, AW0764, AW0765, AW0766, AW0767, AW0768, AW0769, AW0770, AW0771, AW0772, AW0773, AW0774, AW0775, AW0776, AW0777, AW0778, AW0779, AW0780, AW0781, AW0782, AW0783, AW0784, AW0785, AW0786, AW0787, AW0788, AW0789, AW0790, AW0791, AW0792, AW0793, AW0794, AW0795, AW0796, AW0797, AW0798, AW0799, AW0800, AW0804, AW0805, AW0814, AW0817, AW0818, AW0819, AW0820, AW0821, AW0825, AW0826, AW0827, AW0828, AW0830, AW0831, AW0832, AW0833, AW0834, AW0835, AW0836, AW0837, AW0838, AW0839, AW0840, AW0841, AW0842, AW0854, AW0855. |
| Center Classification Date | 20240418 |
| Recall Initiation Date | 20240325 |
| Recalling Firm | SonarMed Inc |
| Initial Notification | Letter |
| Similar To |