Agency classClass IIOur severity:Severe FDA (Devices)·Z-1053-2019·Announced 2019-04-03

Philips UroDiagnost MRF Recall Due to Missing Locking Plate

Philips is recalling UroDiagnost MRF units because a missing locking plate may cause unexpected stand or table tilt movement that users cannot stop.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect that could cause unexpected movement of a medical table, posing a significant injury risk to patients or staff.

Plain-English summary

Philips North America, LLC is recalling the UroDiagnost MRF (Product No. 708033) because the locking plate may be missing from the system. This defect may result in unexpected stand or table tilt movement that cannot be stopped by the user.

The recall covers 1,969 units distributed domestically in the United States and internationally worldwide. Affected serial codes include 1, 2, 3, 4, 5, 7, 8, 11, 13, 14, 15, 16, 17, 18, 21, 48, 59, 60, and 64. The device is used for various urological and gynecological examinations, including urograms, cystography, and cystoscopy.

Healthcare facilities should check their inventory for these specific serial codes and contact Philips North America, LLC for instructions on how to resolve the issue.

The recalled product

Product: Urodiagnost, Product No. 708033 Product Usage: The Philips UroDiagnost MRF can be used to perform all urological and gynecological routine examinations including: Urograms with injection or infusion Retrograde pyelography Cystography and urethrography Micturition…
Manufacturer: Philips North America, LLC
Category: Medical Device — Imaging Equipment
Hazard: structural-defect
injury
Affected units: 1,969

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 (1)

Serial codes 1 2 3 4 5 7 8 11 13 14 15 16 17 18 21 48 59 60 64

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Philips North America, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Philips North America, LLC

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Same hazard · structural defect