Transonic Systems Inc: Software defect; programming errors in the blood flow probes EPROM. Transonic received several complaints from users indicating that when the flow probe is connected to a flow meter the meter reads Used Probe or Irrelevant Use Number.

Agency Publication Date: September 3, 2015

Affected Products

Product: Transonic Flow Probe, 2 mm, Catalog Number HQC2FMC Product Usage: to measure flow intra-operatively.

Serial Numbers: HQC2FMC1801, HQC2FMC 1802, HQC2FMC1805, HQC2FMC1806

Product: Transonic Flow Probe, 3 mm, Catalog Number HQC3FMC -- Product Usage: to measure flow intra-operatively.

Serial Numbers: HQC3FMC2501, HQC3FMC2502, HQC3FMC2503, HQC3FMC2504, HQC3FMC2505, HQC3FMC2506, HQC3FMC2507, HQC3FMC2508, HQC3FMC2509, HQC3FMC2510, HQC3FMC2511, HQC3FMC2512, HQC3FMC2513, HQC3FMC2514, HQC3FMC2515, HQC3FMC2516, HQC3FMC2517, HQC3FMC2518, HQC3FMC2519, HQC3FMC2520, HQC3FMC2521, HQC3FMC2522, HQC3FMC2523, HQC3FMC2524, HQC3FMC2525, HQC3FMC2526, HQC3FMC2527, HQC3FMC2528, HQC3FMC2529, HQC3FMC2530, HQC3FMC2531, HQC3FMC2532, HQC3FMC2533, HQC3FMC2534, HQC3FMC2535, HQC3FMC2636

Product: Transonic Flow Probe, 6 mm, Catalog Number HQC6FMV -- Product Usage: to measure flow intra-operatively.

Serial Number: HQC6FMV2239

Product: Transonic Flow Probe, 8 mm, Catalog Number HQC8FMV -- Product Usage: to measure flow intra-operatively.

Serial Numbers: HQC8FMV2142, HQC8FMV2143, HQC8FMV2144, HQC8FMV2145, HQC8FMV2146

Product: Transonic Flow Probe, 2 mm, Catalog Number HQC2MP -- Product Usage: to measure flow intra-operatively.

Serial Numbers: HQC2MP2763, HQC2MP2764, HQC2MP2769, HQC2MP2771, HQC2MP2772, HQC2MP2773

Product: Transonic Flow Probe, 3 mm, Catalog Number HQC3MP -- Product Usage: to measure flow intra-operatively.

Serial Numbers: HQC3MP4665, HQC3MP4666, HQC3MP4667, HQC3MP4668, HQC3MP4669, HQC3MP4670

Product: Transonic Flow Probe, 2 mm, Catalog Number HQD2FMC -- Product Usage: to measure flow intra-operatively.

Serial Numbers: HQD2FMC2797, HQD2FMC2873, HQD2FMC2874, HQD2FMC2875, HQD2FMC2876, HQD2FMC2877, HQD2FMC2878, HQD2FMC2879, HQD2FMC2880, HQD2FMC2881, HQD2FMC2882, HQD2FMC2883, HQD2FMC2884, HQD2FMC2885, HQD2FMC2886, HQD2FMC2888, HQD2FMC2889, HQD2FMC2890, HQD2FMC2908

Product: Transonic Flow Probe, 3 mm, Catalog Number HQD3FMC -- Product Usage: to measure flow intra-operatively.

Serial Numbers: HQD3FMC3763, HQD3FMC3764, HQD3FMC3765, HQD3FMC3766, HQD3FMC3767, HQD3FMC3768, HQD3FMC3769, HQD3FMC3770, HQD3FMC3771, HQD3FMC3772, HQD3FMC3773, HQD3FMC3774, HQD3FMC3775, HQD3FMC3776, HQD3FMC3777, HQD3FMC3778, HQD3FMC3779, HQD3FMC3780, HQD3FMC3781, HQD3FMC3782, HQD3FMC3783, HQD3FMC3784, HQD3FMC3785, HQD3FMC3786, HQD3FMC3787, HQD3FMC3788, HQD3FMC3789, HQD3FMC3790, HQD3FMC3791, HQD3FMC3792, HQD3FMC3793, HQD3FMC3794, HQD3FMC3795, HQD3FMC3796, HQD3FMC3797, HQD3FMC3798, HQD3FMC3799, HQD3FMC3800, HQD3FMC3801, HQD3FMC3802, HQD3FMC3803, HQD3FMC3804, HQD3FMC3805, HQD3FMC3806, HQD3FMC3807, HQD3FMC3814, HQD3FMC3815

Product: Transonic Flow Probe, 4 mm, Catalog Number HQD4FMC -- Product Usage: to measure flow intra-operatively.

Serial Numbers: HQD4FMC3504, HQD4FMC3505, HQD4FMC3506, HQD4FMC3507, HQD4FMC3508, HQD4FMC3509, HQD4FMC3510, HQD4FMC3511, HQD4FMC3512, HQD4FMC3513, HQD4FMC3514, HQD4FMC3515, HQD4FMC3516, HQD4FMC3517, HQD4FMC3518, HQD4FMC3519, HQD4FMC3520

Product: Transonic Flow Probe, 6 mm, Catalog Number HQD6FMV -- Product Usage: to measure flow intra-operatively.

Serial Numbers: HQD6FMV2469, HQD6FMV2470

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 71907

Status: Resolved

Manufacturer: Transonic Systems Inc

Manufactured In: United States

Units Affected: 10 products (Domestic: 4 units; Domestic: 36 units; Domestic: 1 unit; Domestic: 5 units; Domestic: 6 units; Domestic: 6 units; Domestic: 8 units, foreign: 11 units; Domestic: 35 units, Foreign: 12 units; Domestic: 15 units, Foreign: 2 units; Domestic: 2 units)

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Sources: FDA iRES · Raw API Response

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Affected Products