MobileDiagnost wDR motorized portable diagnostic X-ray systems.
FDA device recall Z-1040-2015 · posted 2015-02-02 · Terminated
Recall details
- Recalling firm
- Sedecal S.A.
- Reason for recall
- Reports of unexpected movement.
- Action taken
- URGENT - Field Safety Notice letters dated August 6, 2014 were sent to all consignees of record. The letters instructed consignees: 1) The unit is equipped with a safety switch in the drive handle. If the drive handle is released the unit will stop; 2) Do not try to correct unintended movement using the controls on the drive handle; 3) Instead, stop the system immediately by releasing the drive handle entirely; 4) Alternatively, the emergency button can be pressed; 5) Take special care when the system crosses metal strips or plates on the floor or enters an elevator, as these are situations where electrostatic discharge is likely to occur; and, 6) Should the customer feel uncertain regarding this action, he/she can contact Philips Healthcare.
- Root cause
- Other
- Status
- Terminated
- Product code
- IZL
- Quantity affected
- 283 systems
- Distribution
- US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NM, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI)
- Date initiated
- 2014-08-06
- Date posted
- 2015-02-02
- Date terminated
- 2016-06-22
- Location
- Algete, Spain
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MOBILEDIAGNOST WDR (K111725) | Sedecal., Sa. | 2011-07-19 |