Recall Z-1140-2019
Philips Medical Systems Nederlands · initiated February 19, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 Product The Allura Xper FD Series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures.
Codes / lots: Foot Switches: 452270000141 Footswitch CV 3p 4m; 452270000151 Footswitch MD 3p 6m; 452270000142 Footswitch CV 3p 4m; 452270000381 Footswitch CV 3p 8m; 452270000382 Footswitch CV 3p 8m; 459800076001 Footswitch CV 4p+2 4m; 459800076021 Footswitch CV 4p+2 8m; 459800415571 Wireless Footswitch 4p+2; 459800415581 Wireless footswitch set 4p+2; 459800415531 Wireless Footswitch 3P; 459800415561 Wireless footswitch set 3P.
Reason for recall
Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is frequently used on a non-flat surface or in the pedestal, the footswitch pedals may get bent. This might cause an intermittent or continuous inability of making live fluoroscopy images or exposures.
FDA-determined cause: Component design/selection
Action taken
The firm previously notified customers on September 24, 2014 as part of Recall Z-1280-2016. On February 21, 2019, the firm sent an updated recall letter to newly identified affected consignees. Customers were alerted that bent pedal of footswitch might cause interruption of live Flouroscopy imaging or exposure. Action to be taken by Customer/User: 1. Before starting a procedure, the user should check the footswitch for possible bent pedals. If bent pedals are found the procedure should not continue and Local Service should be contacted. 2. Do not use the footswitch on an anti-fatigue mat or in the pedestal. 3. Please ensure that all staff with access to the affected systems are informed of the content of this Medical Device Correction. 4. Include this Medical Device Correction together with the documentation of the system until the system has been corrected by Philips. The firm stated that the problem will be resolved by an update of the mechanical hardware of the footswitch which will prevent the pedals of the footswitch from becoming bent. The mechanical hardware was available as of February 2019. Customers will be notified by their local Philips representative to schedule a date for installation of the mechanical hardware update. Technical Support Line: 1-800-722-9377
Details
- Recall number
- Z-1140-2019
- Initiated
- February 19, 2019
- Terminated
- October 14, 2020
- Product code
- IZI – System, X-Ray, Angiographic
- Quantity
- 7209 total
- Distribution
- US Nationwide Distribution in the states of CA, FL, MI, OR, PA, TX and WA.
- Recalling firm
- Philips Medical Systems Nederlands, Best
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1141-2019 Class II | Foot Switches used with the following systems: 722001 Allura Xper FD 10 C 722002 Allura…Additional units have been identified for previous recall Z-1280-2016 (RES 69339): If a Footswitch is… | 02/19/2019Terminated |