Agency classClass IIOur severity:High FDA (Devices)·Z-0761-2016·Announced 2016-02-17

Del Medical VS200 Radiographic Cassette Holder Recall for Falling Hazard

Del Medical is recalling VS200 radiographic cassette holders and wall stands because they can suddenly fall to the ground and contact patients.

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 3/5 (High).

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: The recall is classified as FDA Class II, and the hazard involves a risk of physical injury to patients from a falling device, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Del Medical, Inc. is recalling approximately 4,000 units of the VS200 radiographic Cassette Holder or Wall Stand. These devices are used in radiology departments to hold X-ray cassettes. The recall covers units distributed in the United States, Canada, Costa Rica, Libya, Mexico, and the Philippines.

The recall is being issued because the wall stand cassette holder can suddenly fall to the bottom of its travel, near the ground, and contact a patient. This mechanical failure presents a risk of injury to patients during radiographic procedures.

Healthcare facilities and consumers should stop using the affected VS200 units immediately. Del Medical, Inc. is the recalling firm responsible for managing the recall. Specific serial numbers for the affected units are listed in the official recall documentation.

The recalled product

Product: VS200 radiographic Cassette Holder or Wall Stand. For use in radiology department.
Manufacturer: Del Medical, Inc.
Category: Medical Device — Radiology Equipment
Hazard: falling-object
impact-injury
Affected units: 4,000

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 (20)

Product # Serial # 110-5010G1
00504-0214 110-5010G1
00855-0414 110-5010G1
00182-0114 110-5010G1
00108-0114 110-5010G1
00479-0214 110-5010G1
00014-0114 110-5010G1
00251-0214 110-5010G1
00854-0414 110-5010G1
00505-0214 110-5010G1
00342-0214 110-5010G1
00477-0214 110-5010G1
00184-0114 110-5010G1
00248-0214 110-5010G1
00588-0314 110-5010G1
00852-0414 110-5010G1
00107-0114 110-5010G1
00183-0114 110-5010G1
00480-0214 110-5010G1
00503-0214 110-5010G1

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Del Medical, Inc. 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 2 products in this recall →

Same manufacturer · Del Medical, Inc.

See all →

High
Del Medical VS300 Radiographic Cassette Holder Recall for Falling Hazard
FDA (Devices) · 2016-02-17

Same hazard · falling object