The Recall Desk
HighFDA (Devices)·Z-0416-2022·Announced 2021-12-29

Philips Allura Xper FD Ceiling Monitors Risk Falling Due to Loose Screws

Set screws on ceiling-mounted extra monitors can loosen, causing monitors to fall and potentially injure patients, staff, or service technicians.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II device recall involving a mechanical defect (loose fasteners on ceiling-mounted equipment) that creates a risk of falling equipment and potential injury to patients and staff in a medical setting. No injuries have been reported to date, placing this in the 'High' category per the rubric: risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Philips Allura Xper FD series imaging system, software version 2.1.x, is being recalled because set screws securing the gliding rods of the extra monitors (7th and 8th monitor positions) can come loose from the Monitor Ceiling Suspension (MCS) structure, potentially causing the monitors to disengage and fall.

If ceiling-mounted monitors fall, there is a risk of injury to patients undergoing imaging procedures, clinical staff, or service technicians. The recall notice states that such incidents may require medical intervention.

In the United States, 5 affected systems have been identified in DC, Georgia, Massachusetts, Texas, and Virginia. Worldwide, 15 additional systems are distributed in the Dominican Republic, India, Japan, Poland, Spain, and Taiwan. Affected model numbers are 722005, 722006, 722008, 722010, 722012, 722013, 722025, 722026, 722027, and 722028.

The recalled product

Product
Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. Model Number: 722005, 722006, 722008, 722010, 722012, 722013
Manufacturer
Philips North America Llc
Category
Medical Device — Medical Imaging Equipment
Hazard
  • loose-fasteners
  • falling-equipment
  • injury-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (18)

  • US Serial Number/UDI: 1 (01)00884838054202(21)1
  • 527 (01)00884838059054(21)527
  • 408 (01)00884838054202(21)408
  • 306 (01)00884838054202(21)306
  • 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

Distribution

Distributed nationwide across the United States.

Related recalls

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