Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive) of max. 7 sec. may result in the following reasonably foreseeable injury or damage to the health of patients and/or users
Reason for recall: Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive) of max. 7 sec. may result in the following reasonably foreseeable injury or damage to the health of patients and/or users Distribution: US Nationwide distribution. Quantity: 224 units Lot/code info: UDI Code: 04046768124363 Serial Numbers: 7 10 9 18 16 14 15 17 13 24 21 22 23 20 25 19 26 32 28 29 30 31 27 42 44 45 46 47 48 49 50 51 54 59 60 52 53 56 57 63 67 74 64 68 72 73 65 69 70 71 66 75 77 78 80 81 82 79 89 83 84 85 86 87 88 90 91 93 92 94 95 96 104 105 99 101 100 102 98 106 107 108 97 103 113 111 112 114 115 119 110 116 118 125 127 128 132 129 130 131 123 124 126 138 134 135 137 139 141 142 143 140 154 146 156 145 147 149 148 150 151 155 161 165 166 164 167 169 171 170 157 162 159 158 163 168 172 174 175 178 179 176 177 152 153 180 181 183 185 182 186 193 196 188 195 189 192 194 190 502 503 504 505 506 507 510 508 509 511 512 513 514 516 520 524 523 521 527 518 519 534 535 536 532 533 541 538 539 537 540 544 545 546 547 548 549 553 550 551 554 555 557 558 556 561 563 564 565 566 569 571 572 567 573 581 579 580 583 585 586 587 584 588 589
04046768124363
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.