Reported Dec 29, 2021 · Terminated
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and…
Philips North America LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips North America Llc · 222 Jacobs St · Cambridge, MA · 02141-2289
Is this the product you have?
- Philips Allura Xper
- FD series with Software Version Number2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures
- Model Number
722005722006722008722010722012722013722025722026722027722028
- Lot codes and dates
- US Serial Number/UDI
1 (01)00884838054202(21)1527 (01)00884838059054(21)527408 (01)00884838054202(21)408306 (01)00884838054202(21)30661 (01)00884838059030(21)61
- OUSModel
- Product S/N UDI722006 Allura Xper FD20 1997 (01)00884838059191(10)1997; 722010 Allura Xper FD10 1177 (01)00884838059030(21)1177; 722010 Allura Xper FD10 1178 (01)00884838059030(21)1178; 722013 Allura Xper FD20 Biplane 544;; 722010 Allura Xper FD10 514 (01)00884838059030(21)514; 722013 Allura Xper FD20 Biplane 271; 722025 Allura Xper FD20 Biplane OR Table 6; 722005 Allura Xper FD10/10 519; 722008 Allura Xper FD20 Biplane 531; 722012 Allura Xper FD20 1901 (01)00884838059054(21)1901; 722012 Allura Xper FD20 2505 (01)00884838059054(21)2505; 722013 Allura Xper FD20 Biplane 137; 722026 Allura Xper FD10 439 (01)00884838054189(21)439; 722134 Field ext. Xper vascular systems R7.6 98736; 722027 Allura Xper FD10/10 172 (01)00884838054196(21)172
- US Serial Number/UDI
- Amount recalled
- USA: 5 systems R.O.W.: 15 systems
Where it was sold
Why it was recalled
Set screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come loose, the Extra monitors might disengage from the Mounting Ceiling Suspension structure and fall down, may lead to patient, user or service engineer harm that may require medical intervention.
This product could cause temporary or reversible health problems — stop using it.
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