Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
FUJIFILM Healthcare Americas Corporation · AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent in…
Open FDA's page for this record- Cfres ID
- 207222
- Product res number
- Z-1884-2024
- Event date initiated
- 2024-04-11
- Event date posted
- 2024-05-22
- Recall status
- Open, Classified
- Res event number
- 94441
- Product code
- IYN
- Product description
- Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
- Code info
- UDI-DI: (01) 04580292771704 Noblus Ultrasound Imaging System AC Adapter Serial Number Before K17160001 (Excluding K17160001)
- Firm FEI number
- 1000513161
- Recalling firm
- FUJIFILM Healthcare Americas Corporation
- Address 1
- 81 Hartwell Ave Ste 300 81 Hartwell Ave
- Address 2
- Ste 300
- City
- Lexington
- State
- MA
- Postal code
- 02421-3160
- Additional info contact
- SAME 617-861-5300
- Root cause description
- Device Design
- Product quantity
- 418 units
- Distribution pattern
- US Nationwide distribution.
- Reason for recall
AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).
- Action
FujiFilm issued Urgent Medical Device Recall Letter via email on 4/11/24. Letter states reason for recall, health risk and action to take: Please complete and return the Field Action Verification Form attached on page 3 of this communication. Responding with the information requested is essential for ensuring appropriate action is taken. Please accept the replacement of AC adapter that is implemented the countermeasure. Please contact our field action coordinator, Kotei Aoki, via email at HCUSRegulatoryAffairs@fujifilm.com, if you have any further questions regarding this field action.
- K numbers
- K160559
- Harmonized identifiers (openFDA)
- Device name
- System, Imaging, Pulsed Doppler, Ultrasonic
- Medical specialty description
- Radiology
- Regulation number
- 892.1550
- Device class
- 2
- K number
- K121564, K172342, K231190, K173090, K041916, K020630, K110199, K113663, K131088, K121010, K192254, K102388, K070813, K933916, K202364, K173000, K904017, K032620, K233692, K233610, K240206, K042055, K050380, K250543, K180535, K232336, K230179, K233394, K161525, K170823, K000931, K260748, K053648, K122583, K152396, K120321, K231685, K261211, K142710, K051334 +1,149 more
- PMA number
- P940005
- Registration number
- 3006161756, 3009293490, 3032807464, 3033527241, 3014574557, 3008492462, 3040391009, 9611125, 3010398867, 3043534483, 2518586, 2183744, 3027501622, 3033508292, 3016696283, 1126271, 3008640801, 9615439, 3013368530, 3032109225, 3009196578, 3009758186, 3003851073, 3016842138, 3009247326, 3000976525, 3026047529, 3019784575, 3025429169, 2531814, 3012761544, 9680269, 3042172882, 3010220244, 3012987001, 3017487805, 3001722928, 3047889344, 1058584, 3033557977 +182 more
- FEI number
- 3009293490, 3032807464, 3033527241, 1000114111, 3014574557, 3008492462, 3040391009, 3003861317, 3010398867, 3043534483, 2518586, 2183744, 3027501622, 3002808127, 3033508292, 3016696283, 3008640801, 3003705156, 3013368530, 1000306431, 3032109225, 3000302153, 3009196578, 3009758186, 3003851073, 3016842138, 3009247326, 3000976525, 3026047529, 3019784575, 3025429169, 3012761544, 3042172882, 3010220244, 3012987001, 3017487805, 3001722928, 3047889344, 3033557977, 3008223664 +182 more