| | Class 2 Device Recall Rover |  |
| Date Initiated by Firm | August 31, 2022 |
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| Date Posted | September 23, 2022 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1786-2022 |
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| Recall Event ID |
90839 |
| 510(K)Number | K211423 |
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| Product Classification |
System, x-ray, mobile - Product Code IZL
|
| Product | MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19 |
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| Code Information |
Model Number: MXU-RV19
UDI Codes:
(01)09357123000013(11)210326(21)00222
(01)09357123000013(11)210628(21)00234
(01)09357123000013(11)210629(21)00235
(01)09357123000013(11)210629(21)00236
(01)09357123000013(11)210630(21)00237
(01)09357123000013(11)210708(21)00238
(01)09357123000013(11)210721(21)00240
(01)09357123000013(11)210910(21)00261
(01)09357123000013(11)210913(21)00262
(01)09357123000013(11)210914(21)00263
(01)09357123000013(11)210921(21)00264
(01)09357123000013(11)210922(21)00265
(01)09357123000013(11)210923(21)00266
(01)09357123000013(11)210927(21)00267
(01)09357123000013(11)211006(21)00268
(01)09357123000013(11)211008(21)00269
(01)09357123000013(11)211011(21)00270
(01)09357123000013(11)211011(21)00271
(01)09357123000013(11)211012(21)00272
(01)09357123000013(11)211013(21)00273
(01)09357123000013(11)211013(21)00274
(01)09357123000013(11)211210(21)00288
(01)09357123000013(11)211213(21)00289
(01)09357123000013(11)211213(21)00290
(01)09357123000013(11)220329(21)00305
(01)09357123000013(11)220330(21)00306
(01)09357123000013(11)220331(21)00307
(01)09357123000013(11)220401(21)00308
(01)09357123000013(11)220404(21)00309
(01)09357123000013(11)220405(21)00310
(01)09357123000013(11)220406(21)00311
(01)09357123000013(11)220404(21)00312
Serial Numbers:
222
234
235
236
237
238
240
261
262
263
264
265
266
267
268
269
270
271
272
273
274
288
289
290
305
306
307
308
309
310
311
312 |
| FEI Number |
3012855798
|
Recalling Firm/
Manufacturer |
Micro-X Ltd.
A14 6 MAB Eastern Promenade
Tonsley
Australia
|
Manufacturer Reason
for Recall | Software calibration error with product equip with a Dose Area Product (DAP) meter. This results in the product displaying the incorrect DAP meter values which may impede radiation exposure management decisions |
|---|
FDA Determined
Cause 2 | Process control |
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| Action | On or about 09/31/2022, the firm sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via email/telephone to customers informing them that during an internal data analysis on 08/18/2022, Micro-X Ltd identified software calibration errors with the product equipped with a Dose Area Product (DAP) meter. This resulted in the product displaying incorrect DAP meter values. The DICOM image produced by the system will report a DAP measurement in microgray/square meter that is 8 to 10 times lower than the actual dose delivered.
Customers are instructed to:
1. Inspect their stock immediately and place the Recall Notification Letter on the affected product and quarantine affected product on hand to prevent further use.
2. Contact the nominated Service representative to arrange the re-calibration of the DAP Meter. Email: support-us@micro-x.com or Phone 1-206-249-8764.
3.Previous version of Service Documentation (ROV208-2 Acceptance and Compliance Testing Instructions) which includes inaccurate DAP calibration processes are to be removed from use.
4. Complete and return Acknowledgement and Receipt Form immediately to Micro-X LTD in Australia: support@micro-x.com and copy djerkovic@micro-x.com
5. Ensure relevant staff members are informed of the Recall and if affected units have been supplied/transferred to another facility, inform them immediately.
For question or further assistance, contact Regulatory Affairs Manager at djerkovic@micro-x.com |
|---|
| Quantity in Commerce | 42 units |
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| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of CA, NV, NY, OH, TX and WA and the countries of Australia, France, Israel, Japan, and United Arab Emirates. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = IZL
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